Medical device for treatment of a sinus and/or an ear and methods of use thereof

ABSTRACT

There is provided herein, a device for treating and/or diagnosing a sinus or an ear condition, the device comprising a housing comprising or functionally connected to: a hollow cannula defining a lumen extending at least partially along the length thereof, the cannula is configured to be at least partially inserted through an ostium into a sinus cavity/ear of a subject; and a flexible grinding wire movable within the cannula&#39;s lumen and configured to be inserted into and retrieved out of the sinus cavity through the cannula&#39;s lumen, and to rotate along a longitudinal axis thereof and thereby grind, chop and/or stir material present in the sinus cavity and/or inside the hollow cannula, wherein the cannula is in fluid flow communication with an irrigation/aspiration source; and a wire handle functionally connected to the wire, allowing a user to advance and retrieve the wire within the cannula and into and out of the cannula lumen, wherein the device is handheld by a gripping handle.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 16/313,246 filedDec. 26, 2018 which is a National Phase of PCT Patent Application No.PCT/IL2017/050744 having an International filing date of Jul. 3, 2017,which claims the benefit of priority of U.S. Provisional ApplicationNos. 62/358,017 filed on Jul. 3, 2016, 62/393,317 filed on Sep. 12,2016, and 62/487,122 filed on Apr. 19, 2017. The contents of the aboveapplications are all incorporated by reference as if fully set forthherein in their entirety.

TECHNICAL FIELD

The present disclosure generally relates to the field of devices andmethods for treatment and/or diagnosis of sinus conditions.

BACKGROUND

Paranasal sinus conditions such as sinusitis, annually affects nearly 35million patients in the United States alone. It can be due to infection,allergy or autoimmune problems, with a majority of cases being due to aviral infection, aerobes bacteria and anaerobes bacteria. The exactcause of sinusitis might be unclear to a health care provider assymptoms may be undistinguishable. Facing this uncertainty, thetreatment of the condition is commonly carried out by administeringvarious medications and/or providing various treatments thus determiningthe actual cause through a method of elimination of potential causes. Asa result, the patient may be exposed to unnecessary drugs or procedures.

Another possibility is to surgically penetrate the paranasal sinus bypuncturing through the paranasal sinus bones or by breaking the bonesaround the paranasal sinus natural opening for taking samples anddetermining the cause of the condition. Treatment can be administeredduring such surgery, for example by a process known as lavage orirrigation and aspiration. Many complications are associated with thesesurgical options; therefore, health providers tend to be reluctant inexecuting them unless necessity calls for it in acute cases.

There is thus a need in the art to provide devices, systems and methodsallowing diagnosis and treatment of paranasal sinus conditions, withoutexposing the patient to unnecessary medication and/or massively invasivesurgical intervention.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods, which aremeant to be exemplary and illustrative, not limiting in scope. Invarious embodiments, one or more of the above-described problems havebeen reduced or eliminated, while other embodiments are directed toother advantages or improvements.

According to some embodiments, there are provided herein devices,systems and methods for treating and/or diagnosing a sinus (such as aparanasal sinus) and/or an ear condition using a hollow cannula whichmay access the sinus/ear through the natural opening, therebyfacilitating diagnosis and/or treatment of the sinus conditions withouta surgical dilation or an expansion.

According to some embodiments, there is provided herein a medical devicefor treating and/or diagnosing a sinus and/or ear condition, the medicaldevice comprising: a housing comprising or functionally connected to: ahollow cannula defining a lumen extending at least partially along thelength thereof, the cannula is configured to be at least partiallyinserted through an ostium into a sinus cavity/ear of a subject; and aflexible grinding wire movable within the cannula's lumen and configuredto be inserted into and retrieved out of the sinus cavity through thecannula's lumen, and to rotate along a longitudinal axis thereof andthereby grind, chop and/or stir material present in the sinus cavityand/or inside the hollow cannula, wherein the cannula is in fluid flowcommunication with an irrigation/ aspiration source; and a wire handlefunctionally connected to the wire, allowing a user to advance andretrieve the wire within the cannula and into and out of the cannulalumen, wherein the device is handheld by a gripping handle.

According to some embodiments, there is provided herein a medical kitfor treating and/or diagnosing a sinus or an ear condition, the kitcomprising: a device comprising: a housing comprising or functionallyconnected to: a hollow cannula defining a lumen extending at leastpartially along the length thereof, the cannula is configured to be atleast partially inserted through an ostium into a sinus cavity/ear of asubject; and a flexible grinding wire movable within the cannula's lumenand configured to be inserted into and retrieved out of the sinus cavitythrough the cannula's lumen, and to rotate along a longitudinal axisthereof and thereby grind, chop and/or stir material present in thesinus cavity and/or inside the hollow cannula, wherein the cannula is influid flow communication with an irrigation/aspiration source; a wirehandle functionally connected to the wire, allowing a user to advanceand retrieve the wire within the cannula and into and out of the cannulalumen; and a guiding tube configured to house the cannula therein andbend the cannula as it is being advanced forward, and direct a distalend of the cannula towards a sinus opening, wherein the device ishandheld by a gripping handle; a connector configured for replacing ofguiding tubes; and a set of replaceable guiding tubes having differentangles at a distal section thereof for fitting to different sinusanatomies.

According to some embodiments, the device may further include a cannulahandle functionally connected to the cannula, allowing a user to advanceand retrieve the cannula into a sinus cavity or an ear.

According to some embodiments, the device may further include a guidingtube configured to house the cannula therein and bend the cannula as itis being advanced forward, and direct a distal end of the cannulatowards a sinus (or an ear) opening.

According to some embodiments, the device may further include a curve inthe cannula distal tip and a cannula rotating mechanism, configured toallow the user to rotate a distal tip of the cannula around alongitudinal axis of the cannula, thus facilitate insertion of thecannula into the sinus cavity. The cannula's rotating mechanism mayinclude a dial allowing the user to rotate the distal tip of thecannula, for example, with the same hand, which is holding the device.

According to some embodiments, the device may further include aconnector configured for replacing of (e.g., disposable) guiding tubes.

According to some embodiments, the device may further include amechanism for changing an angle of a distal section of the guiding tube,to facilitate introduction of the cannula to various sinus anatomies.

According to some embodiments, the device may further include a shaft,wherein at a distal section thereof, the shaft is connected to the wireand at a proximal section thereof, the shaft is connected to a motorconnected to the wire handle, wherein the motor provides rotationalmovement to the shaft, which transmits this movement to the wire.According to some embodiments, the motor itself is the wire handle.According to some embodiments, the wire directly connects to the motor,without a shaft. According to some embodiments, the wire handle protectsthe user from touching the wire and facilitates distal and proximalmovement of the wire while the wire is rotating.

According to some embodiments, the motor may be configured to be atleast partially within the device body. The motor and the device bodymay be detachably connectable.

According to some embodiments, the device may further include a liquidtube connected at a distal section thereof to a proximal side of thecannula and at a proximal section thereof to the irrigation/aspirationsource, such that the liquid tube is in fluid flow connection with thecannula and the irrigation/aspiration source, wherein an inner diameterof the liquid tube is larger than an inner diameter of the cannula, andwherein at least part of the shaft is located within the liquid tubelumen. According to some embodiments, the shaft may be supported withinthe liquid tube by one or more mechanisms that are configured to reducea friction and/or vibration between the shaft and the liquid tube.According to some embodiments, a distal end of the shaft and/or aproximal end of the liquid tube comprise a mechanism configured toprevent liquid occlusion in the cannula and/or the liquid tube when theshaft is being advanced distally toward a connection point between thecannula and the liquid tube.

According to some embodiments, the irrigation/aspiration source mayinclude a replaceable syringe, a syphon, and/or a liquid container.

According to some embodiments, the device may further include acannula/liquid tube seal located within a defined lumen within thehousing and surrounding at least portion of the cannula/liquid tube,such that the cannula/liquid tube is distally/proximally movable withinthe lumen and relative to the handle grip while remaining thecannula/liquid tube cavity sealed from air inlet and liquid outletduring irrigation and aspiration. The cannula/liquid tube seal mayfurther be configured to facilitate rotation of the cannula/liquid tuberelative to the handle grip while the cannula/liquid tube remainssealed.

According to some embodiments, the device may further include awire/shaft seal surrounding at least a portion of the wire/shaft andfacilitating distal/proximal movement of the wire/shaft within andrelative to the cannula/liquid tube, while maintaining thecannula/liquid tube sealed from air inlet and liquids outlet duringirrigation and aspiration. The wire/shaft seal may further be configuredto facilitate high RPM rotation of the wire/shaft within and relative tothe cannula/liquid tube, while the cannula/liquid tube remains sealed.

According to some embodiments, the device may further include anirrigation/aspiration seal configured for connection and/or detachmentof the irrigation/aspiration source to the liquid tube/cannula in asealed manner

According to some embodiments, the device may further include a cannulaposition marking configured to provide the user indication about thecannula's distal end location and/or orientation in relation to a sinusopening.

According to some embodiments, the device may further include a wireposition marking configured to provide the user indication about thewire's distal end location and/or orientation in relation to thecannula's distal end.

According to some embodiments, the device may further include aconnector connecting between the liquid tube/cannula and the shaft/wiresuch that when the liquid tube/cannula is moved distally the shaft/wirewill also be distally moved, for at least part of the liquidtube/cannula advancement.

According to some embodiments, the device may further include a lockingmechanism for locking the cannula at a certain position. The lockingmechanism may be manually or automatically operable and is located in orconnected to the cannula handle.

According to some embodiments, the device may further include a sideport in the guiding tube, wherein the side port is configured forinstrumentation insertion through a distal end of the guiding tube. Theside port may be configured to serve as an aspiration port in fluid flowconnection with a distal end of the guiding tube, wherein the aspirationport is configured for suction of aspiration/irrigation fluid from theguiding tube. The aspiration port may be connectable to a suctionmachine.

According to some embodiments, the gripping handle is essentiallyperpendicular to the longitudinal axis of the device. According to someembodiments, the irrigation/aspiration source may be at least partiallyhoused within the gripping handle.

According to some embodiments, the device may further include a hollowtrocar configured to house the cannula therein, puncture a sinus wall,sinus floor or ear wall and facilitate insertion of the cannula into thesinus/ear cavity. The cannula may be configured to puncture via an earor a sinus wall or sinus floor as a trocar. According to someembodiments, the device may further include a spring activated mechanismconfigured to control and limit the trocar puncturing movement. A distalend of the trocar may be configured to irrigate or aspirate liquidsthrough a lumen thereof to/from an irrigation/aspiration sourceconnected proximally to the trocar distal end. According to someembodiments, the terms “trocar” and “needle” may be usedinterchangeably.

According to some embodiments, the terms “ostium”, “opening” and“natural opening” may be used interchangeably.

According to some embodiments, the cannula may be configured to beinserted into a sinus cavity or an ear cavity through an endoscopeworking channel. According to some embodiments, the cannula (forexample, a stiff or a flexible cannula) and the wire may be configuredto be inserted into a sinus cavity or an ear cavity through an endoscopeworking channel. According to some embodiments, the endoscope itself isconfigured to enter the sinus cavity or an ear cavity and the wire isconfigured to be inserted into a sinus cavity or an ear cavity throughthe endoscope working channel.

According to some embodiments, the device may further include a sinusopening dilation mechanism, mounted on a distal end of the cannula.

According to some embodiments, the cannula may be a rigid bent (curved)cannula, configured to be inserted into the sinus cavity. According tosome embodiments, the device may further include a tubular membersurrounding the bent cannula, a distal end of the tubular member isconfigured to face a sinus or ear opening and to irrigate and/oraspirate liquid through the tube to an irrigation/aspiration sourceconnected to the tubular member proximally to its distal end. Accordingto some embodiments, the bent cannula may be inserted into a sinuscavity, a first irrigation aspiration source irrigates the sinus via thecannula, while the wire is rotating within the sinus or the ear cavity,and a second irrigation/aspiration source aspirates the irrigation outof the sinus or ear opening.

According to some embodiments, the device may further includevisualization equipment located within or mounted on a distal tip of theguiding tube. According to some embodiments, the device may furtherinclude a visualization equipment attachment mechanism located within ormounted on a distal tip of the guiding tube.

According to some embodiments, there is provided herein a method fortreating and/or diagnosing a sinus or an ear condition, the methodcomprising: utilizing a device comprising a housing comprising orfunctionally connected to: a hollow cannula defining a lumen extendingat least partially along the length thereof, the cannula is configuredto be at least partially inserted through an ostium into a sinuscavity/ear of a subject; and a flexible grinding wire movable within thecannula's lumen and configured to be inserted into and retrieved out ofthe sinus cavity through the cannula's lumen, and to rotate along alongitudinal axis thereof and thereby grind, chop and/or stir materialpresent in the sinus cavity and/or inside the hollow cannula, whereinthe cannula is in fluid flow communication with an irrigation/aspirationsource; a wire handle functionally connected to the wire, allowing auser to advance and retrieve the wire within the cannula and into andout of the cannula lumen; and a guiding tube configured to house thecannula therein and bend the cannula as it is being advanced forward,and direct a distal end of the cannula towards a sinus opening, whereinthe device is handheld by a gripping handle, advancing a distal end ofthe guiding tube towards the ostium; operating the cannula handle toadvance the cannula within a guiding tube and through the ostium into acavity of the sinus/ear; operating the wire handle to distally advancethe wire out of the cannula and into the sinus cavity; and activatingthe motor to induce rotation of the wire. The method may further includeproviding irrigation fluid to the sinus cavity via the cannula.

According to some embodiments, the device cannula is not movable and notflexible, as described above, but stiff and fixed. According to thoseembodiments the cannula will be described as a tubular member with adistal curved end. According to some embodiments, the curved distal endis intended to be inserted into patient sinus. According to someembodiments, the curved distal end is configured to be inserted into themaxillary sinus. According to some embodiments, the curved distal end isconfigured to be inserted into the frontal sinus. According to someembodiments, the curved distal end is configured to be inserted into thesphenoid sinus. According to some embodiments, the curved distal end isconfigured to be inserted into the ear Eustachian tube. According tosome embodiments, the curved distal end might have angles of 110-90 forthe maxillary sinus, 0-30 for the sphenoid sinus, 60-80 for the frontalsinus, 30-70 for the Eustachian tubes. According to some embodiments,the distal end might be bendable or malleable. According to someembodiments, it might be bendable by the user hands, and according toothers it may be bendable using a bending jig.

According to some embodiments, the curved distal end comprises anatraumatic tip. According to some embodiments, the atraumatic tip has around or a ball shape. According to some embodiments, the atraumatic tipand or curved distal end has one or more holes for irrigation and oraspiration. According to some embodiments, at least some of the holesare side holes. According to some embodiments, the atraumatic tipcontains a guide wire, a lens, a light source, a camera or anycombination thereof.

According to some embodiments, the rotating wire is capable of rotatinginside the curved distal end during sinus irrigation via the curveddistal end. According to some embodiments, the rotating wire is capableof rotating inside the curved distal end during sinus irrigation andsinus aspiration via the curved distal end. According to someembodiments, the rotating wire protrudes out of the curved distal end.According to some embodiments, the rotating wire protrudes out of theatraumatic tip. According to some embodiments, the rotating wireprotrudes out of the curved distal end or atraumatic tip is sideprotrusion.

According to some embodiments, the device's tubular member is within anaspiration tube. The aspiration tube has a proximal end and distal end.At least a part of the tubular member distal curved end is not coveredby the aspiration tube. According to some embodiments, the tubularmember distal curved end is capable of being at least partially insertedinto a patient's sinus or Eustachian tube, while the aspiration tube isnot inserted into the sinus or Eustachian tube. According to someembodiments, the tubular member distal curved end is capable ofproviding irrigation and or aspiration while the aspiration tube isaspirating the liquids spilled out of the sinus. According to someembodiments, the tubular member distal curved end is capable ofproviding irrigation and or aspiration while the rotating wire isrotating within the tubular member distal curved end and or within thesinus and while the aspiration tube is aspirating the liquids spilledout of the sinus. According to some embodiments, the aspiration tube isconnected to an aspiration machine or to a syringe. According to someembodiments, the aspiration tube or the connector has a T or Y shape andit has a connection to a suction machine or a syringe via the aspirationtube. According to some embodiments, the aspiration tube or theconnector or a proximal aspiration tubing has a syphon mechanism tocollect aspirated liquids or specimens from the sinus. According to someembodiments, the aspiration tube distal end is atraumatic. According tosome embodiments, the aspiration tube distal end is made of softmaterial and or collapsible construction such as foam. According to someembodiments, the soft material and or collapsible construction such asfoam, circumference the distal end of the tube. According to someembodiments, the soft material and or collapsible construction such asfoam has a ring shape and it is located proximally to the aspirationtube distal end. According to some embodiments, a ring may be attachedto the sinus ostium during sinus irrigation and aspiration. According tosome embodiments, the ring may seal the sinus opening during irrigationand may prevent irrigation liquid flow from the sinus to the nasalcavity.

According to some embodiments, the device is configured to be insertedinto a sinus cavity via an endoscope. According to some embodiments, thedevice is configured to be inserted into a sinus cavity via an endoscopeworking channel. According to some embodiments, the endoscope is aflexible endoscope. According to some embodiments, the flexibleendoscope comprises actuation mechanisms that allow the user to controlits distal tip curve.

According to some embodiments, the device is configured such as that theendoscope working channel might replace or serve as the guiding tube.According to those embodiments, the cannula might be inserted into anendoscope inner lumen and into the sinus cavity. According to thoseembodiments, the cannula and wire actuation and sealing mechanisms willbe as described above.

According to some embodiments, the device is configured such that theendoscope working channel might replace or serve as the cannula and orthe liquid tube. According to those embodiments, the wire might beinserted into an endoscope inner lumen and into the sinus cavity.According to those embodiments, the wire actuation and sealingmechanisms will be as described above.

According to some embodiments, the device guiding tube or cannula mightcomprise: a straight support element having a first rigidity; a curvedsupport element, slideably coupled to the straight support element, thecurved support element having a curved portion, the curved portion ofthe curved support element having a second rigidity greater than thefirst rigidity, at least the curved portion having rectangular crosssection; and a rigid straight support element slideably coupled to thecurved support element, the rigid straight support element having athird rigidity greater than the second rigidity, when the rigid straightsupport element overlaps the curved portion of the curved supportelement, an overlapped portion of the curved portion conforms to astraight shape of the rigid straight support element, and when thecurved portion overlaps the straight support element, an overlappedportion of the straight support element conforms to a curved shape ofthe curved portion. According to some embodiments, such endoscope iscomprised of least one work channel.

According to some embodiments, the device guiding tube or cannula mightcomprise: a first support element configured to move from asubstantially straight configuration to a curved configuration defininga radius of curvature, the first support element having a rectangularcross section; a second support element configured to slideably moverelative to the first support element such that when the second supportelement overlaps the first support element, the first support element isin its straight configuration; and a third support element, at least aportion of which is configured to have the radius of curvature of thefirst support element when it overlaps the first support element.According to some embodiments, such endoscope includes at least one workchannel.

According to some embodiments, the movable seal, that keeps the liquidtube sealed despite the liquid tube movement backward and forward, maybe replaced by a part of the liquid tube that is expandable, such asexpandable tubing. According to some embodiments, the expandable part ofthe liquid tube can rotate and transmit torque in order to connectbetween the cannula and the dial, such as the movable seal. According tosome embodiments, the expandable part comprises support, such as aspring, or a spiral spring, to transmit the rotation from the dial tothe cannula.

According to some embodiments, the device comprises a manual rotationmechanism instead of a motor. According to some embodiments, the manualrotation mechanism may include any mechanism for manually spinning theshaft.

Certain embodiments of the present disclosure may include some, all, ornone of the above advantages. One or more technical advantages may bereadily apparent to those skilled in the art from the figures,descriptions and claims included herein. Moreover, while specificadvantages have been enumerated above, various embodiments may includeall, some or none of the enumerated advantages.

In addition to the exemplary aspects and embodiments described above,further aspects and embodiments will become apparent by reference to thefigures and by study of the following detailed descriptions.

More details and features of the current invention and its embodimentsmay be found in the description and the attached drawings.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In case of conflict, the patentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Examples illustrative of embodiments are described below with referenceto figures attached hereto. In the figures, identical structures,elements or parts that appear in more than one figure are generallylabeled with a same numeral in all the figures in which they appear.Alternatively, elements or parts that appear in more than one figure maybe labeled with different numerals in the different figures in whichthey appear. Dimensions of components and features shown in the figuresare generally chosen for convenience and clarity of presentation and arenot necessarily shown in scale. The figures are listed below.

FIGS. 1A and 1B schematically illustrate a device for treating aparanasal sinus condition in retracted and opened configurations,respectively, according to some embodiments;

FIGS. 2A and 2B schematically illustrate a device for treating aparanasal sinus condition in retracted and opened configurations,according to some embodiments;

FIGS. 3A-3C schematically illustrate a longitudinal cross sectional viewof a device for treating a paranasal sinus condition in retracted,partially opened, and opened configurations, respectively, according tosome embodiments;

FIG. 3D shows an enlargement of a distal portion of the device FIG. 3C,according to some embodiments;

FIG. 3E shows an enlargement of a portion of the device FIG. 3C,according to some embodiments;

FIG. 3F shows an enlargement of a portion of the device FIG. 3C,according to some embodiments;

FIG. 3G shows an enlargement of a proximal portion of the device FIG.3C, according to some embodiments.

FIG. 4A shows a distal portion of a device for treating a paranasalsinus, according to some embodiments;

FIG. 4B shows a distal portion of a device for treating a paranasalsinus, according to some embodiments;

FIG. 4C shows a distal portion of a device for treating a paranasalsinus, according to some embodiments;

FIG. 5A shows a partially transparent view of distal portion of a devicefor treating a paranasal sinus, according to some embodiments;

FIG. 5B shows a partially transparent view of distal portion of a devicefor treating a paranasal sinus, according to some embodiments;

FIG. 6A shows a partially transparent view of a distal end of a cannulaof a device for treating a paranasal sinus condition and a wireprotruding distally therefrom in an opened configuration, according tosome embodiments;

FIG. 6B shows a distal end of a cannula of a device for treating aparanasal sinus condition and a wire protruding distally therefrom in anopened configuration, according to some embodiments;

FIG. 6C shows a perspective view of the distal end of the cannula ofFIG. 6A, according to some embodiments; and

FIG. 6D shows a distal end of a cannula of a device for treating aparanasal sinus condition and a wire protruding distally therefrom in anopened configuration, according to some embodiments.

DETAILED DESCRIPTION

In the following description, various aspects of the disclosure will bedescribed. For the purpose of explanation, specific configurations anddetails are set forth in order to provide a thorough understanding ofthe different aspects of the disclosure. However, it will also beapparent to one skilled in the art that the disclosure may be practicedwithout specific details being presented herein. Furthermore, well-knownfeatures may be omitted or simplified in order not to obscure thedisclosure.

According to some embodiments, there is provided a medical device fortreating and/or diagnosing a paranasal sinus condition. As used herein,the term “paranasal sinus” refers to an air-filled space that surroundsthe nasal cavity. The paranasal sinuses include, but are not limited tothe area located under the eyes; the frontal sinuses above the eyes; theethmoidal sinuses between the eyes; the sphenoidal sinuses behind theeyes, and the middle ear cavity.

According to some embodiments, there are provided herein devices,systems and methods for treating and/or diagnosing paranasal sinusconditions using a hollow cannula which may access the paranasal sinusthrough the natural paranasal sinus opening, thereby facilitatingdiagnosis and/or treatment of the paranasal sinus conditions withoutsurgical puncturing, dilation or expansion.

There is provided, according to some embodiments, a device for diagnosisand/or treatment of paranasal conditions including a flexible hollowcannula configured to be inserted to a paranasal sinus through a naturalopening thereof. The flexible hollow cannula is shaped to reach adesired treatment area within the paranasal sinus. The flexible hollowcannula is at least partially housed in and movable within a guidingtube with a bent/bendable distal end configured to be inserted to anasal cavity through a nostril, such as to face a natural opening of aparanasal sinus.

During a treatment and/or a diagnosis procedure, a healthcare providermay introduce the distal end of the guiding tube to the nasal cavity ofa subject. A distal portion of the guiding tube may be bent so as toface a natural opening of a paranasal sinus. Alternatively, the distalportion of the guiding tube includes a predefined bent allowing it toface a natural opening of a paranasal sinus. The flexible hollow cannulamay protrude distally from the guiding tube into the natural opening tothe paranasal sinus. According to some embodiments, when the protrudingportion or the hollow shaft is extended, it assumes a relaxed shape thatallows reaching a treatment area within the paranasal sinus.

According to some embodiments, the flexible hollow cannula may beconfigured to penetrate through and/or be inserted into the ostiumwithout requiring prior surgical dilation or expansion. That is, theflexible hollow cannula may be sized and shaped to enter the sinusthrough a natural sized opening thereof. According to some embodiments,the hollow cannula may have an external diameter of 2.5 mm or below, 2.0mm or below, 1.5 mm or below, 1.3 mm or below, 1.2 mm or below, 1.1 mmor below, or 1 mm or below. Each possibility represents a separateembodiment.

According to some embodiments, the flexible hollow cannula houses agrinding wire configured to grind, chop and/or stir mucus material. Asused herein the term “mucus material” may refer to mucus, fungus,bacteria, biofilm, soft polyps, mucusal soft tissue, irrigation fluidsor any other material or combination of materials present in the sinuscavity and/or within the hollow cannula.

According to some embodiments, the wire is connected to a motor.According to some embodiments, the wire and the motor are interconnectedby a transmission shaft (“shaft”). Optionally, a proximal end of thewire is coupled to a distal portion of the transmission shaft. Accordingto some embodiments, a proximal end of the transmission shaft isconnected directly to the motor. Alternatively or additionally, theproximal end of the transmission shaft is connected to a motor gear. Insome embodiments, the transmission shaft may be a plastic or metal rodor tube such as a steel rod. According to some embodiments, thetransmission shaft includes more than one shaft. According to someembodiments, the transmission shaft comprises a gear. According to someembodiments, the transmission shaft is supported by one or morebearings. According to some embodiments, the transmission shaft issupported by a plurality of bearings. According to some embodiments, thetransmission shaft may be advanced and retrieved through the pluralityof bearings.

According to some embodiments, the device includes a casing having adistal end and a proximal end. According to some embodiments, thedevice's casing distal end is connected to the tubular member. Accordingto some embodiments, the casing includes within it at least one of thefollowing: a cannula, a liquid tube, a wire, a wire transmissionmechanism, a syringe/ irrigation/ suction connector, and a motorconnector. According to some embodiments, the casing houses within it atleast a portion of the motor. According to some embodiments, the casinghouses within it or is coupled to an irrigation and/or aspirationmechanism. According to some embodiments, the irrigation and/oraspiration mechanism includes a syringe. According to some embodiments,the irrigation and/or aspiration mechanism is motorized.

According to some embodiments, a Y or a T connector interconnects thewire transmission and the liquid tube to the cannula. The connectionbetween the Y or T connector to the cannula may be direct or via aliquid tube. Non-limiting examples of liquid tubes include plastic ormetal tubing such as a steel tube. According to some embodiments, theliquid tube houses at least part of the wire transmission and the wire.According to some embodiments, the liquid tube is coupled to the guidingtube or the tubular member. According to some embodiments, the liquidtube is coupled to the tubular member and to the cannula.

According to some embodiments, the casing includes a gripping handlewhich may enable a user (such as a doctor, nurse or a technician) tohold the device. According to some embodiments, a gripping handleenables the user to hold the device in a pencil like grip. According tosome embodiments, the gripping handle is fitted to contain a syringewithin it, or at least partially within it. According to someembodiments, the casing is fitted to contain a syringe within it, or atleast partially within it. According to some embodiments, the grippinghandle or casing is fitted only for a certain size syringe. That way,using too big a syringe can be prevented. According to some embodiments,the syringe size limitation is for syringes with size less then: 60, 50,40, 30, 20, 10 ml. According to some embodiments, the user can grip thesyringe and the gripping handle with the same hand.

According to some embodiments, the device includes a syringe sealmechanism. According to some embodiments, the syringe may be attached tothe gripping handle or casing in a sealed manner According to someembodiments, the syringe may be releasably fitted into the grippinghandle or casing. According to some embodiments, the gripping handle orcasing may be fitted to one or more tubes that connect the Y or Tconnector to an exterior irrigation and or suction in a sealed manner(in the text it will be called syringe seal despite it possibly beingother kinds of irrigation and aspiration sources).

According to some embodiments, the gripping handle or casing is fittedto house two syringes, a first syringe for irrigation and a secondsyringe for aspiration. According to some embodiments, the aspirationsyringe is bigger than the irrigation syringe to provide the highnegative pressure needed for viscus mucus suction without the risk ofcreating too high a pressure in the sinus. According to someembodiments, the syringes might have one direction flow valve, such as aduckbill valve. Such one-way valves are needed to prevent air and liquidflow from one syringe to the other and reduced affect in the sinuscavity. Yet according to additional embodiments, the flow into and outof the syringes can be controlled with a switch or a handle or a tap.

According to some embodiments, the gripping handle includes a mechanismthat controls the syringe. According to some embodiments, pressing thegripping handle advances or retrieves the syringe piston while a firstspring presses the piston to the other direction. According to someembodiments, upon pressing the gripping handle it returns into itsoriginal location by a second spring. According to some embodiments, thegripping handle may move the syringe piston with a ratchet mechanism,such as a linear ratchet.

According to some embodiments, the syringe piston is controlled by anactuator. According to some embodiments, the actuator is a motorizedactuator. According to some embodiments, the actuator is a motorizedsyringe pump. According to some embodiments, the syringe pump ispositioned in the device gripping handle or in the device casing.According to some embodiments, the syringe pump is positioned outside ofthe device gripping handle or in the device casing.

According to some embodiments, the cannula may be advanced and retrievedusing a handle (cannula handle). According to some embodiments, thecannula handle is connected to the liquid tube. According to someembodiments, the cannula is located inside the device casing and thecannula handle outside of the device casing. According to someembodiments, the cannula handle slips over the device casing. Accordingto some embodiments, the device casing has an open side tunnel Accordingto some embodiments, at least one pin ribbon or screw is connecting thecannula handle to the cannula or liquid tube, and the pin ribbon orscrew is movable back and forward within the tunnel

According to some embodiments, the cannula handle enables one handinsertion and retrieval of the cannula. According to some embodiments,the user can grip the syringe, the gripping handle, and the cannulahandle with the same hand. According to some embodiments, the cannulahandle may be controlled using the user index finger of the same handthat holds the device. According to some embodiments, the cannula handlemay be controlled using the user thumb of the same hand that holds thedevice. In some embodiments, the cannula handle has a lever that enableslonger advancement of the cannula in relation to the cannula handleadvancement. In other embodiments, the cannula advancement is linear tothe cannula handle advancement. In some embodiments, the cannula and thecannula handle may both move together forward and backward along thesame linear axis. According to some embodiments, the cannula may beadvanced up to 10, 20, 30, 40, 50, 60 mm into the sinus. Eachpossibility represents a separate embodiment.

According to some embodiments, pressing the gripping handle advances orretrieves the cannula or the liquid tube. According to some embodiments,following the pressing of the gripping handle, a spring returns it toits original position. According to some embodiments, the grippinghandle moves the cannula or the liquid tube with a ratchet mechanism,such as a linear ratchet.

According to some embodiments, the cannula may provide tactile feedbackvia the cannula handle when it is subject to resistance such as from anasal mucosa, a infundibulum, a sinus ostia, or a sinus wall and sinuslower part. Such tactile feedback may assist the user to locate thecannula position in space and make decisions regarding the amount offorce he may apply on the device and cannula handle. Therefore, thetactile feedback may prevent the user from harming and injuring thepatient.

According to some embodiments, the device shall have visual marks thatindicate the distance the cannula distal tip has advanced over thetubular member distal tip. Such visual feedback may assist the user tolocate the cannula position in space and make decisions regarding theamount of force he may apply on the device and cannula handle.Therefore, the tactile feedback may prevent the user from harming andinjuring the patient.

According to some embodiments, the cannula handle has a mechanism thatlocks it from advancing or retrieving. The mechanism may be released bypushing or moving a trigger. Such a trigger may prevent unintendedcannula retrieval from the patient sinus. According to some embodiments,the trigger may be controlled with the same hand that is moving thecannula handle and holding the device. According to some embodiments,the trigger is positioned such that it may be pushed or moved by thesame movement that advances or retrieves the cannula handle. Accordingto some embodiments, the trigger is positioned such that it may bepushed or moved in the same direction as the cannula handle movement.According to some embodiments, the trigger is based on a spring orspring like mechanism. The spring may push or pull one or moreprotrusions fitted into one or more sockets. That way the trigger canprevent or allow movement of the cannula handle.

According to some embodiments, the locking mechanism such as theprotrusions and sockets is not active during the initial advancementlength. According to some embodiments, it is positioned only in thedistal part of the device handle overlapping area. That way the frictionof the initial cannula movement is reduced. According to someembodiments, the initial cannula advancement distance is less than 5,10, 15, 20 mm (each possibility represents a separate embodiment).According to other embodiments the locking mechanism is based onfriction.

According to some embodiments, the cannula handle is capable of rotatingthe cannula around its central axis in addition to back and forthmovement. According to some embodiments, cannula handle rotationalmovement linearly rotates the cannula. According to some embodiments,cannula handle movement rotates the cannula using a lever or a gear.According to some embodiments, cannula handle movement may rotate thecannula using a string. According to some embodiments, the cannulahandle may bend the cannula distal end using one or more strings.According to some embodiments, the cannula handle may pull a string thatcauses the cannula to bend in one direction and a spring to bend thecannula to the opposite direction. According to some embodiments, thestrings are located outside of the cannula interior lumen. According tosome embodiments, the strings are located in additional interior lumenor lumens. According to some embodiments, the same cannula handlecontrols at least: forward and backward movement and rotational movementand cannula distal end bending. According to some other embodiments,more than one cannula handle may control at least: forward and backwardmovement and rotational movement and cannula distal end bending.

According to some embodiments, the cannula handle has a mechanicalconnection to the liquid tube via an aperture in the device casing.According to some embodiments, the cannula handle has a magneticconnection to the liquid tube. The handle and or the liquid tube containmagnets and there is no need for an aperture in the device casing.

According to some embodiments, a rotating cannula handle may rotate thecannula around its axis. According to those embodiments, a rotatingcannula handle is an additional handle to the cannula handle. Accordingto some embodiments, the user may hold the device handle by one hand androtate the cannula handle with the same hand. According to thoseembodiments, a rotating cannula handle may be used by the device userusing a different finger than the finger he uses to advance and retrievethe cannula handle. According to those embodiments, the user may rotatethe rotating cannula handle and to advance or retrieve the cannulahandle simultaneously. According to some embodiments, he might do itusing only one hand. According to some embodiments, a rotating cannulahandle is or comprises a dial or a cannula dial.

According to some embodiments, the rotating cannula handle or dial ismechanically connected to the liquid tube, or to the cannula. Rotationof the dial, rotates the cannula around its axis. According to someembodiments, the cannula distal end is not straight. According to someembodiments, it comprises a curve. According to some embodiments, thecannula distal end has 10, 20, 30, 40 degrees bend, each possibilityrepresents a separate embodiment. According to some embodiments,rotation of the dial, liquid tube and or cannula, may facilitate cannulainsertion into a patient's sinus, by providing better orientation towarda sinus ostium.

According to some embodiments, the rotating cannula handle is directlyconnected to the cannula. According to some other embodiments, therotating cannula handle is in-directly connected to the cannula. Theindirect connection can include a gear, a lever, a bulge or a rod.According to some embodiments, the rotating cannula handle is locatednear the device handle and the connection between the rotating cannulahandle to the cannula is located distally to the device's distal cannulaseal. According to some embodiments, the dial rotating cannula handle ordial comprises a protrusion or a lever that connects it to the cannulaover the device distal cannula seal. According to some embodiments, theconnection between the rotating cannula handle to the cannula is linear.According to some embodiments, the connection between the rotatingcannula handle to the cannula is not linear.

According to some embodiments, the connection apparatus between therotating cannula handle and the cannula is located outside of the devicecasing. According to some embodiments, the connection apparatus isconnected to the cannula distally to the device distal cannula seal.According to some embodiments, the connection apparatus between therotating cannula handle and the cannula is located within the devicecasing. According to some embodiments, at least part of the rotatingcannula handle or dial is located within the device casing. According tosome embodiments, the device casing comprises one or two or moreopenings. The openings may enable the user to rotate the dial while thedevice casing distal part is connected to the device casing proximalpart.

According to some embodiments, the liquid tube comprises one tube thatconnects the cannula and the T or Y connector. According to someembodiments, the liquid tube comprises more than one tube that connectsthe cannula and the T or Y connector. According to some embodiments, theliquid tubes are movable and at least one of them can be inserted intoat least one other tube inner lumen in a telescopic manner It isunderstood that during such movement the connection between the tubesremains to be sealed, such as by 0-rings seals. The sealed telescopictube mechanism might be beneficial in shortening the device length.

According to some embodiments, the device comprises a handle (wirehandle) that advances and retrieves the rotating wire. According to someembodiments, the wire handle advances the wire transmission shaft.According to some embodiments, the wire transmission shaft and wire arelocated inside the device casing and the handle outside of the devicecasing. According to some embodiments, the outer wire handle and theinner wire transmission shaft are connected via an open tunnel in thedevice casing side (as the cannula handle). According to otherembodiments, the connection is located on the proximal end of the devicecasing.

According to some embodiments, the wire handle might advance, retrieveor rotate the wire transmission shaft in comparison to the liquid tubeand or the T or Y connector. According to some embodiments, the wirehandle is positioned proximally to the liquid tube and or the T or Yconnector. According to some embodiments, the wire handle is connectedto a proximal part of the wire transmission shaft that protrudes out ofthe liquid tube and or the T or Y connector. According to someembodiments, the wire handle slips over the device casing proximal part.According to some embodiments, at least part of the handle slips insidethe device casing proximal part. According to some embodiments, the wirehandle and the device casing contain rails that prevents the handlerotation relative to the device casing. According to some embodiments,the wire handle and/or the device casing contain a stopper mechanismsuch as pins that prevent the handle from separating from the devicecasing. According to some embodiments, the wire handle has a magneticconnection to the wire transmission shaft. According to someembodiments, the wire handle is connected to the wire transmission shaftvia an aperture in the liquid tube side wall. The aperture in the liquidtube is sealed by a seal, around the handle. According to someembodiments, the seal in the liquid tube is movable, collapsible orstretchable. According to some embodiments, the seal is not movable, andthe wire handle uses a gear in order to advance and retrieve the wiretransmission shaft. According to some embodiments, the wire handle andthe wire transmission shaft contain a magnetic connection and there isno need for an aperture in the device casing or in the liquid tube orthe need to position the wire handle in the device proximal part.

According to some embodiments, the wire handle advances and retrievesthe wire transmission shaft and the rotating wire within the cannula andout of the cannula. According to some embodiments, the wire handleadvances and retrieves the wire transmission shaft and the rotating wirewithin the tubular guide and out of the tubular guide.

In some embodiments, the wire handle has a lever that enables longeradvancement of the wire in relation to the handle advancement. In otherembodiments, the wire advancement is linear to the handle advancement.In some embodiments, the wire and the handle are both moving togetherforward and backward along the same linear axis. According to someembodiments, the device shall have visual marks that indicate thedistance the wire distal tip has advanced. Such visual feedback mayassist the user to locate the wire position in space in relation to thesinus and the cannula. According to some embodiments, the wire may beadvanced up to 10, 20, 30, 40, 50, 60, 70 mm into the sinus (eachpossibility represents a separate embodiment).

According to some embodiments, the device has a mechanism that moves oneof the wire or cannula handles in the same direction as the otherhandle, as a result of the other handle's movement. According to someembodiments, the movement is partial. According to some embodiments,moving the cannula/liquid tube forward advances the wire in the samedirection. According to some embodiments, the movement starts only afterthe cannula has been advanced over a certain point. According to someembodiments, the certain point distance is less than 10, 20, 30, 40, 50mm (each possibility represents a separate embodiment). According tosome embodiments, both handles are connected. According to someembodiments, the liquid tube and the wire transmission may be connectedduring advancement/retrieval. According to some embodiments, theconnection may be by a bump or a pin, that drags the other part as itmoves in a certain direction.

According to some embodiments, the liquid tube contains at least part ofthe wire transmission shaft that is connected to the wire. According tosome embodiments, the liquid tube or the wire transmission has one ormore bumps that prevent the wire transmission shaft distal end fromentering into the cannula and or being proximate to the cannula proximalend. That way the bump prevents the wire transmission shaft from partialor full occlusion of the device.

According to some embodiments, the connection between the liquid tubeand the wire transmission shaft is sealed by the movable seal (which canalso be referred to as the cannula seal). According to some embodiments,the movable seal is surrounding part of the wire transmission shaft andis contained within part of the liquid tube. According to someembodiments, the movable seal has a toroid shape. According to someembodiments, the seal can move forward and backward. According to someembodiments, the seal is connected or partially connected to the cannulahandle for at least part of it path. According to some embodiments, thecannula handle movement can linearly progress the seal for at least partof it path. According to some embodiments, the seal comprises one ormore O-rings. According to some embodiments, the seal movement can pressthe liquids within the liquid tube toward the Y or T connector andtoward the syringe or motorized suction irrigation machine. The pressingability is beneficial in collecting mucus from within the device, suchas for lab analysis. Without the ability to press the mucus out of thedevice, a bigger part of the mucus might get lost. An additionalattribute of the movable seal is that it enables it to shorten thedevice length.

According to some embodiments, the movable seal does not undesirablymove forward and backward because of the irrigation and aspirationliquids pressures, due to the cannula handle locking mechanism. Thecannula handle locking mechanism locks the cannula, unless the userpresses the cannula handle. Otherwise irrigation and aspiration liquidpressure changes could force the cannula out of the patient's sinus.

According to some embodiments, the device has an additional proximalseal (motor seal). The proximal seal seals the connection between the Yor T connector and the motor. The proximal seal is crucial forsimultaneously rotating the wire and irrigation or aspiration of thesinus cavity. Simultaneously rotating the wire and irrigation oraspiration is needed for creating the liquids shear forces that cleanthe mucus out of the sinus cavity areas without direct contact with thegrinding wire. Additionally, simultaneously rotating the wire andaspiration is needed for preventing cannula/ liquid tube occlusion.Occlusion may occur due to the mucus sticky nature and the mucus abilityto restore its viscosity after tearing apart within seconds.

According to some embodiments, the proximal seal is a magnetic seal.Rotation of a proximal/exterior magnet connected to the motor isrotating additional distal/interior magnet within the proximal end ofthe Y or T connector. The additional magnet is connected to the wiretransmission shaft. Between the magnets, there is a sealed wall.According to some embodiments, the magnets or the wire transmissionshaft may contain a bearing mechanism in order to reduce the friction.

According to some embodiments, the proximal seal is surrounding the wiretransmission shaft that connects the wire to the motor. According tosome embodiments, the proximal seal is affixed to the device casing andthe transmission shaft is rotating within the seal. According to someembodiments, the transmission shaft can be linearly advanced andretrieved within the seal. According to some embodiments, thetransmission shaft can be advanced and retrieved within the seal by thewire handle while the motor is rotating the transmission shaft.According to some embodiments, the seal is made of one or more O-rings.According to some embodiments, the O-rings are pressing the innertransmission shaft. According to some embodiments, the O-rings are beingpressed by its surrounding cavity. According to some embodiments, theO-rings are pressed from its surrounding cavity and pressing thetransmission shaft simultaneously. According to some embodiments, theO-rings are surrounded and pressed by additional O-rings. According tosome embodiments, one of the O-rings is softer than the other. Accordingto some embodiments, the seal is lubricated with oil or grease such assilicone oil or silicone grease. According to some embodiments, the sealcontains a reservoir of lubrication materials.

According to some embodiments, the proximal seal is asliding/contact/plain—bearing. According to some embodiments, theproximal seal bearing is comprised of a stator and a rotor. According tosome embodiments, one of the stator and a rotor may be made of metalsuch as steel and the other one may be made of silicon or plastic suchas Teflon. According to some embodiments, the non-metallic part can beflexible and press the metallic part. According to some embodiments, theconnection between the bearing sides is the connection between thereusable motor and the disposable distal tip. According to doseembodiments the bearing sides connect with a fast connection mechanismsuch as a click or a snap.

According to some embodiments, the proximal seal is a Labyrinth seal.One side of the labyrinth seal is connected to the engine and the otherone is connected to the transmission shaft or to the rotating wire.According to some embodiments, the labyrinth seal contains within itsoft or expandable parts or springs that improve the contact between theLabyrinth seal stator and rotor. According to some embodiments, thelabyrinth seal contains within it a lubrication or sealing medium suchas oil or grease.

According to some embodiments, the device has a sealed cavity formedbetween the syringe/suction/irrigation machine, the proximal seal(connection with the motor), the liquid tube and the cannula, with anopening only at the distal part of the cannula. According to someembodiments, the sealed cavity remains sealed during one or more of thefollowing: syringe piston movement, suction, irrigation, motor rotatingof the wire transmission shaft and the wire, cannula and or liquid tubeadvancement or retrieval, wire and wire transmission shaft advancementor retrieval. The opening of the sealed cavity is only at the distalpart of the cannula. According to some embodiments, the sealed cavityremains sealed due to the simultaneous action of the cannula seal, theproximal seal, and the syringe seal. The sealed cavity that remainssealed during the device parts insertion into the sinus and duringdevice activity is crucial for its ability to provide efficient sinuslavage.

According to some embodiments, the guiding tube or the tubular member isdirectly connected to the device casing. According to other embodiments,the guiding tube or the tubular member is connected to the device casingwith a tubular member connector.

According to some embodiments, the tubular member connector may enablethe user to change the tubular member orientation and rotate it.According to some embodiments, the tubular member connector may enablethe user to replace the guiding tube. According to some embodiments, thetubular member connector connects the cannula by a snap or threadingmechanism such as a luer. According to some embodiments, the guidingtube luer is a locking luer. According to some embodiments, the lockingluer threading nut is capable of locking the guiding tube in everyorientation. The threading nut rotates and threads itself on thestationary guiding tube. That way the user might change the guiding tubeorientation and/or replace the guiding tube at will.

According to some embodiments, the guiding tube, or at least part of it,is bendable. According to some embodiments, the guiding tube may be bentby the device user to fit to the shape of a creation sinus ostia orother nasal structure, or to facilitate ostial penetration. According tosome embodiments, the device kit may be comprised of a guiding tubebender, that may be used to bend the guiding tube to desired shapes.According to some embodiments, the guiding tubes might be bent to anglesof 110-90 for the maxillary sinus, 0-30 for the sphenoid sinus, 60-80for the frontal sinus, 30-70 for the Eustachian tubes.

According to some embodiments, the device kit might contain more thanone guiding tube with different angles intended for different sinuses,such as the maxillary sinus, frontal sinus, sphenoid sinus, the middleear via the Eustachian tube. According to some embodiments, the guidingtubes might have angles of 110-90 for the maxillary sinus, 0-30 for thesphenoid sinus, 60-80 for the frontal sinus, 30-70 for the Eustachiantubes.

According to some other embodiments, the guiding tube can be bent.According to some other embodiments, the guiding tube can be bent so thedistal end of the tube may face at least one of the nasal cavitiesopenings. According to some other embodiments, the guiding tube can bebent with a controlling handle. According to some other embodiments, theguiding tube can be bent by the device user using his/hers hands orusing a bending device or a jig. According to some embodiments, theguiding tube can have bending angles of 110-90 for the maxillary sinus,0-30 for the sphenoid sinus, 60-80 for the frontal sinus, 30-70 for theEustachian tubes.

According to some other embodiments, the guiding tube can be bent.According to some other embodiments, the guiding tube can be bent so thedistal end of the tube may face at least one of the nasal cavitiesopenings. According to some other embodiments, the guiding tube can bebent with a controlling handle. According to some other embodiments, theguiding tube can be bent by the device user using his/hers hands orusing a bending device or a jig. According to some embodiments, theguiding tube can have bending angles of 110-90 for the maxillary sinus,0-30 for the sphenoid sinus, 60-80 for the frontal sinus, 30-70 for theEustachian tubes.

According to some embodiments, the guiding tube is suitable to containone cannula. According to some other embodiments, the guiding tube issuitable to contain more than one cannula. According to some otherembodiments, the guiding tube is suitable to contain one or moredevices. The device has a proximal and distal end. It can be advancedforward and backwards. It can be advanced over the guiding tube distalend.

According to some other embodiments, the guiding tube distal end has acut conic shape within its interior lumen. That shape can enable onlyone cannula or one device to protrude out of the guiding tube distalend. Additionally, that shape will center the cannula or device on theguiding tube central axis. According to some embodiments, the cannulasor the devices might be connected to the guiding tube with a spring. Thespring is configured to retract the cannula or device that protrudes outof the guiding tube distal end. A pin, a handle, or other mechanismmight be used to resist the spring. According to some embodiments,advancement of one cannula or device while another cannula or device islocated in the guiding tube distal end, will activate the retractingspring of the cannula or device that is located in the guiding tubedistal end.

According to some embodiments, the device can be an additionaltherapeutic and diagnostic instrument such as, guidewire, light-wire fortrans-illumination, optic fiber for visualization or recording, opticfiber for pathogen eradication, swab, cutting device, balloon,dilatation device, vibrating piezoelectric crystal, laser or heatsource, absorbable material soaked with drug, all the above are separateembodiments.

According to some embodiments, the device can be a piston that can pushor suck a material. According to some embodiments, the piston can push adrug into the sinus. According to some embodiments, the drug can be anon-liquid state such as gel, foam or solid state. According to someembodiments, the piston can push a drug via the guiding tube conicdistal end into a sinus cavity. According to some embodiments, theguiding tube may be comprised of an exterior mechanism that seals thesinus ostium opening, such as a foam ring that surrounds the guidingtube.

According to some embodiments, the removable connector may be comprisedof a T or a Y connector. The connector may contain a locking luer.According to some embodiments, the locking luer threading nut is capableof locking the guiding tube in every orientation. The threading nutrotates and threads itself on the stationary guiding tube. According toother embodiments, the guiding tube may have an additional side tube onits side, creating an interior lumen of Y or T shape.

According to some embodiments, the additional tube of the connector orguiding tube may be fitted for suction, such as a connection to asuction machine. Additionally, according to some embodiments, theproximal part of the guiding tube may be sealed around the cannula.According to some embodiments, such seal is comprised of one or more0-rings. Additionally, according to some embodiments, the seal islocated around the cannula or around the liquid tube in the guiding tubeconnector or in the device casing. The seal enables the cannula movementforward and backward with minimal friction. That way the device mightprevent or at least reduce liquid flow from the irrigated sinus to thenasal cavity. Those liquid are a major discomfort for the patients,especially with the bitter taste of local anesthesia. In other cases,therapeutic drugs, pathogens or bacteria may be suctioned, instead offlowing into the nasal cavity, throat or lungs.

According to some embodiments, the additional tube of the connector orguiding tube may be fitted for guidewire insertion. According to someembodiments, the guidewire is a light wire. Such light wire may assistthe user by transillumination of the sinus in order to verify the sinusactual location. According to some embodiments, the additional tube ofthe connector or guiding tube may be fitted for irrigation as well assuction. According to some embodiments, the additional tube of theconnector or guiding tube may be fitted for additional therapeutic anddiagnostic instruments, such as optic fiber for visualization, swab,cutting device, balloon, dilatation device or a grasper.

According to some embodiments, the guiding tube or the tubular memberhas an atraumatic distal end. According to some embodiments, theatraumatic distal end is smooth. According to some embodiments, thetubular member distal end is soft or collapsible. According to someembodiments, the tubular member distal end has a circumstancing ring ofsoft or collapsible material, such as foam. According to someembodiments, the ring of soft or collapsible material can seal the sinusopening. According to some embodiments, the ring can prevent irrigationliquids from flowing into the nasal cavity. According to someembodiments, the distal tip of the guiding tube may include therein ormounted thereon, visualization equipment such as a camera, a lens, alight source or a combination thereof. According to some embodiments,the distal tip of the guiding tube may include therein or mountedthereon, an attachment mechanism for visualization means such as anendoscope. Such visualization equipment can assist the user to see thesinus opening and facilitate cannula insertion. According to someembodiments, the device motor is connected or has a connector to thedevice casing. According to some embodiments, the device motor is atleast partially located within the wire handle. According to someembodiments, the connection enables fast connection and removal of themotor from the device. According to some embodiments, the device casingfully or partially surrounds the device motor. According to someembodiments, the motor is connected to the device casing or wire handlefrom its side. According to some embodiments, the motor is connected tothe device casing wire handle from its proximal end. According to someembodiments, the device casing has a mechanism that prevents the motorfrom falling off. According to some embodiments, the mechanism is an0-ring. According to other embodiments it is a snap connector. Accordingto some embodiments, it is a handle. According to some embodiments, aspring fixes the motor handle in a position that prevents the motor fromdisconnecting the device. Pressing the motor handle against the springenables motor disconnecting.

According to some embodiments, the motor is an electric motor. Accordingto some embodiments, the motor is configured to rotate the transmissionshaft and or rotating wire. According to some embodiments, the motor isconfigured to advance and retrieve the transmission shaft and orrotating wire along a logistical axis. According to some embodiments,the motor is a piezoelectric crystal that vibrates the transmissionshaft and or rotating wire. According to some embodiments, the vibrationis ultrasonic. According to some embodiments, the motor or piezoelectriccrystal is configured to vibrate the device cannula. According to someembodiments, the motor or piezoelectric crystal is configured to vibratethe device cannula. According to some embodiments, the motor orpiezoelectric crystal is configured to vibrate the device guiding tubeor bent shaft. According to some embodiments, the vibration isconfigured to vibrate the mucus. According to some embodiments, thevibration is configured to vibrate the nasal and sinus mucosa. Accordingto some embodiments, the vibration is configured to vibrate the sinusostial mucosa. Vibration of thickened nasal or sinus mucosa can reduceits liquid content, and shrink its size without harming it. It can bebeneficial in restoring mucosal clearance, opening mucosal occlusions,and airing the sinuses.

According to some embodiments, the flexible hollow cannula includes anaperture in its side wall at a distal end thereof, such that theflexible grinding wire may exit the flexible hollow cannula through theaperture. It is understood that such configuration may enable sealing ofthe distal end of the hollow cannula with an atraumatic tip. Accordingto some embodiments, the atraumatic tip may include a taper that directsthe wire towards the side aperture. It is further understood that byexiting the hollow cannula through the aperture, the grinding wire maybe directed away from sensitive areas where it could potentially causeharm. According to some embodiments, the cannula side aperture isconfigured to direct the flexible grinding wire toward a desiredlocation, such as towards a polyp or polypoid tissue. According to someembodiments, the cannula can be advanced, retrieved and rotated in orderto position the side aperture in front of or away from a desiredlocation. According to some embodiments, the cannula aperture ispositioned towards the sphenoid sinus dorsal or medial wall, and awayfrom possible blood vessel in the sinus. According to some embodiments,the cannula aperture is positioned towards the maxillary sinus dorsal ormedial wall, and away from the eye. According to some embodiments, thecannula can have more than one aperture on its distal end. According tosome embodiments, the cannula apertures may be round or elliptic.

According to some embodiments, the grinding wire may be configured toprevent, loosen and/or remove mucus material accumulating and/orclogging the hollow cannula. According to some embodiments, the grindingwire may be configured to scrape, loosen and/or remove material stickingto the walls of the sinus cavity. According to some embodiments, theflexible grinding wire may have an external diameter of 0.5 mm or below,0.4 mm or below, 0.3 mm or below, 0.24 mm, 0.2 mm or below or 0.1 mm orbelow. Each possibility is separate embodiment. According to someembodiments, the wire is made of more than two strings each having anexternal diameter of 0.5 mm 0.1 mm or below, 0.08 mm or below, 0.05 mmor below. Each possibility is a separate embodiment. According to someembodiments, the flexible grinding wire may include a super-elasticmaterial. According to some embodiments, the super-elastic material maybe a pseudo-elastic material. According to some embodiments, thesuper-elastic material may be a Nickel-Titanium alloy.

According to some embodiments, the wire is comprised of more than onematerial and or structure. According to some embodiments, the wire iscomprised of a distal part and a proximal part. According to someembodiments, the distal part is more flexible. For example, according tosome embodiments, the wire is made of a nitinol wire in its proximal endand nitinol cable loop or L in its distal end. The nitinol wire cantransmit the torque in the bent cannula or guiding tube, and the nitinolcable loop or L shape stirs the liquids in the sinus without harming themucosa. According to some embodiments, a crimped metal tube connects thewire distal and proximal parts. According to some embodiments, a plastictube connects the wire distal and proximal parts. According to someembodiments, the tube is a heat shrink plastic tube. According to someembodiments, the wire is comprised of a plastic optic fiber capable ofbending and of transmitting light.

According to some embodiments, the device comprises a non-linear shapeof the grinding wire distal end to facilitate liquids stiffing and mucusgrinding. For example, rotation of wires with L or J distal shapescreates higher liquid movement than rotation of a straight wire.Rotation of a loop was empirically found to create significantly highereffect on mucus grinding in comparison to curved distal shapes.According to some embodiments, the device comprises a loop in thegrinding wire distal end to facilitate liquid stiffing and mucusgrinding.

According to some embodiments, a cable such as a steel or nitinol cabletransmits the transmission between the transmission shaft and the wiredistal end. According to some embodiments, the wire diameter is equal orless than about 0.8 mm, 0.6 mm, 0.4 mm, 0.35 mm, 0.3 mm, 0.24 mm, 0.2mm, each possibility represents a separate embodiment. According to someembodiments, the wire distal end comprises a nitinol loop. According tosome embodiments, the loop diameter is equal or less than 3 cm, 2 cm, 1cm, 5 mm According to some embodiments, a metal crimp connects the cableand the nitinol wire loop. According to some embodiments, the nitinolloop is a symmetric loop. According to some embodiments, the nitinolloop is not a symmetric loop. According to some embodiments, the nitinolloop can be advanced and retrieved out of and into the cannula distalend or cannula side opening. According to other embodiments, the nitinolloop can be partially inserted into the cannula distal end. According tosome embodiments, the nitinol loop shape enables the loop proximal partto be inserted into the cannula distal end but the distal part of sidenitinol loop cannot be inserted into the cannula distal opening.According to some embodiments, the nitinol loop shape has curves,protrusions or kinks that prevent it from full insertion into thecannula distal end. According to some embodiments, the nitinol loopdistal end size, while partially being inserted into the cannula, isequal or less than 3 mm, 2 mm, 1 mm, 0.8 mm, 0.5 mm, each possibilityrepresents a separate embodiment. According to some embodiments, thenitinol loop comprises more than one wire, for example, it can becomprised of two or more loops, or it can be comprised oftree wires. Inthose embodiments the nitinol loop may have a 3D cage shape.

According to some embodiments, the nitinol loop, when it is mounted onthe cannula distal end, may be inserted into a patient's sinus openingwith the cannula. According to some embodiments, the nitinol loop isbeing used as an atraumatic cannula tip. According to some embodiments,advancement of the cannula handle forward advances the cannula and thenitinol loop forward, such as into a sinus opening. According to someembodiments, advancement of the wire handle advances the wire and thenitinol loop out of the cannula. According to some embodiments,advancement of the wire and the nitinol loop out of the cannula distalend enables the nitinol loop to assume its original shape. According tosome embodiments, retrieving of the wire and the nitinol loop into thecannula distal end reduces the loop distal end size. According to someembodiments, the user can rotate the distal nitinol loop orientation byrotating the motor. According to some embodiments, the rotation mayfacilitate cannula insertion into the sinus ostium, for example bybetter fitting to the ostium orifice shape.

According to some embodiments, the nitinol loop lateral sides aresymmetrical. According to some embodiments, the nitinol loop lateralsides are not symmetrical, and the nitinol loop has offsite angle.According to some embodiments, the nitinol loop angle is equal or lessthan about 60, 40, 30, 20, 10 degrees, each possibility represents aseparate embodiment. According to some embodiments, the user can rotatethe distal bent nitinol loop by rotating the motor, while pushing andpulling the cannula handle back and forth. According to someembodiments, the angle may facilitate cannula insertion into the sinusostium, for example, by more easily finding the sinus ostium, or bybetter cannula distal end alignment with the sinus ostium.

According to some embodiments, the user may insert the cannula and thenitinol loop into a patient's sinus within a guiding tube and using thecannula handle, advance the nitinol loop deeper into a patient's sinususing the wire handle, the loop assumes its pre-shaped structure, theuser may rotate the loop using the motor, irrigate and aspirate thesinus via the cannula into a syringe, while the loop is rotating,retrieve the nitinol loop proximal end into the cannula and remove thecannula.

According to some embodiments, at least part of the wire is a compositematerial with metallic core, such as a nitinol rope, and exteriorplastic cover. According to some embodiments, the plastic covering isstiffer than the inner core. According to some embodiments, the plasticcovering has better pushability capability than the flexible metal core,so it will not get entangled around itself while it is advanced forward.According to some embodiments, the plastic covering reduces interiorwire wear and tear during high RPM rotation. According to someembodiments, the plastic covering prevents the metal strings from moveaway from each other. According to some embodiments, the plasticcovering is a heat shrink. According to some embodiments, the plasticcover may have a wall size of 0.1 mm or below, 0.5 mm or below, 0.01 mmor below, 0.05 mm or below or 0.01 mm or below. Each possibility is aseparate embodiment.

According to some embodiments, the distal end of the flexible hollowcannula comprises an atraumatic tip. According to some embodiments, thedistal end of the flexible hollow cannula or the atraumatic tipcomprises a therapeutic or diagnostic device. According to someembodiments, such therapeutic or diagnostic device may be operatedduring sinus irrigation and or aspiration and or during wire rotation.According to some embodiments, the therapeutic or diagnostic device maybe operated before or after sinus irrigation and or aspiration withoutremoving the flexible hollow cannula distal tip out of the patient'ssinus ostium. According to some embodiments, the therapeutic ordiagnostic device may be operated before or after sinus irrigation andor aspiration without removing the hollow shaft distal tip out of itlocation in the nose: facing the patient's sinus ostium.

According to some embodiments, the therapeutic or diagnostic device islocated in the hollow shaft distal end. According to some embodiments,the therapeutic or diagnostic device is located in the hollow shaftdistal end and it may be operated during sinus irrigation and oraspiration and or during wire rotation. According to some embodiments,the therapeutic or diagnostic device may be operated before or aftersinus irrigation and or aspiration without removing the hollow shaftdistal tip out of the patient sinus ostium.

According to some embodiments, the therapeutic or diagnostic device maycontain an optic fiber, electric wire, a lens, a light source such asLED, or any combination thereof. Sinus transamination may help the userto verify the distal tip location within the sinus. According to someembodiments, a laser may be used to take sinus dimensions and improvedevice orientation within the sinus. Sinus illumination may also providetherapeutic value by removing bacteria from the sinus mucosa. Accordingto some embodiments, the device's distal tip may emits light by a lightsource or may transmit light into the sinus. According to someembodiments, the light destroy or damage at least some of the bacteriain the sinus. According to some embodiments, the light may beultraviolet or blue light such as: 250-270 nm, 200-280 nm ultraviolet A,B or C irradiation, 402-420 nm, 400-470. According to some embodiments,the light may provide photodynamic therapy in which the lightilluminates a photosensitizer such as methylene blue, and thephotosensitizer harms bacteria in the sinus. Other photosensitizers mayinclude Allumera, Photofrin, Visudyne, Levulan, Foscan, Metvix, Hexvix,Cysview and Laserphyrin, with others in development, e.g. Antrin,Photochlor, Photosens, Photrex, Lumacan, Cevira, Visonac, BF-200 ALA,Amphinex and Azadipyrromethenes.

According to some embodiments, the light may be diffused by the stiffingliquids in the sinus cavity. According to some embodiments, the stiffingwire stirs the liquids in the sinus cavity and the liquids diffuse thelight over the sinus walls.

According to some embodiments, the light and the optic fiber are capableof detecting Oxidative Stress. According to some embodiments, the lightand the optic fiber are configured to detect the structure, size anddensity of blood vessels in the mucosa. According to some embodiments,the light green such as around 605 nm or around NIR 830. According toother embodiment the light and the optic fiber uses laser Doppler todetect structure, size and density of blood vessels in the mucosa.Structure, size and density of blood vessels may assist in determiningthe mucosal disease severity. Inflammation cases increased blood flow tothe mucosa. Determining the mucosal disease severity might affect theuser decisions regarding the optimal course of treatment. For example,blood vessel increased size and density might imply that the patient haschronic disease and it might require corticosteroids or surgicalsolution. According to some embodiments, the user can use the light todetect the hyper-vascular/inflamed mucosa focal location in relation tothe sinus/nasal map.

According to some embodiments, the liquids stiffing by the wire duringillumination may act as a lens and enable illumination of more extensiveparts of the sinus wall than illumination without liquid stiffing.

According to some embodiments, the therapeutic or diagnostic device maycontain camera, lens, optic fiber that enable taking pictures or videofrom the sinus internal cavity, or any combination thereof. Imaging ofthe sinus internal cavity may enable the user to verify the devicelocation within the sinus, to locate the device in optimal position, tomake decisions on the most appropriate treatment options, to make adecision for how long the sinus irrigation should continue and providevisual feedback if the treatment was successfully completed. Accordingto some embodiments, the pictures are video pictures. According to someembodiments, the device contains separate optic fibers for illuminationand for taking pictures. According to some embodiments, the devicecomprises a screen or a connection to a screen. According to someembodiments, the cannula may include on a distal tip thereof,visualization equipment (such as a camera) that may be directed towardsthe rotating wire, and may provide pictures of the rotating wire.

According to some embodiments, the therapeutic or diagnostic device maycontain an ultrasonic imaging mechanism. According to some embodiments,the therapeutic or diagnostic device may contain an ultrasonic mark suchas a sound opaque mark or sonic beacon to be used with an exteriorultrasound device. According to some embodiments, the mark may enablethe user to verify the device location within the nasal cavity.According to some embodiments, the therapeutic or diagnostic device maycontain a radio mark such as a radio opaque mark or radio beacon to beused with an exterior radio device. According to some embodiments, themark may enable the user to verify the device location within the nasalcavity. According to some embodiments, the device can comprise amagnetic mark and a magnetic exterior device for the same purposes.According to some embodiments, the device can comprise a light orradiation emitting mark, and an exterior light or radiation sensingdevice for the same purposes. According to some embodiments, thetherapeutic or diagnostic device may contain a thermal beacon, such asLED (Light-emitting diode) to be used with an exterior thermal imagingdevice. According to some embodiments, the thermal beacon may enable theuser to verify the device location within the nasal cavity. According tosome embodiments, the exterior thermal imaging device is a thermalcamera suitable to be used with a mobile device such as a cellphone or atablet.

Some embodiments describe a method in which the user may use a thermalimaging device on a patient's sinuses to sense if the sinus area ishotter than its environment. According to some embodiments, the thermalimaging device is a thermal camera suitable to be used with a mobiledevice such as a cellphone or a tablet. The user may then insert intothe patient's nasal cavity or sinus a guidewire/light wire/curvedshaft/balloon dilation device, containing a thermal source such as LEDin its distal end. The user may then verify the thermal source locationin the nasal cavity using the thermal imaging device. Alternatively, theuser may follow the thermal source movement in the nasal cavity usingthe thermal imaging device. The user may then preform surgicalintervention in the nasal cavity or the sinus such as sinus ostialballoon dilatation or biopsy. The user may then lavage the nasal cavityor the sinus cavity. The user may then use the thermal imaging device tosee that the temperature in the sinus was reduced by the lavage(immediately or in additional doctor visits). Each step may constituteseparate embodiments.

According to some embodiments, the therapeutic or diagnostic device maycontain a pressure sensor or a strain gauge. The pressure sensor or astrain gauge may be used to measure the pressure within the sinus, toavoid excess pressure, pain and injury, or to identify the device tiplocation in relation to the sinus wall and avoid excess pressure on thesinus mucosal wall or bottom, pain and injury, or to measure the sinusostium diameter in order to provide the user better clinicalunderstanding to assess the next surgical steps, such as ostialdilatation.

According to some embodiments, the therapeutic or diagnostic device maycontain a lab on a chip, to analyze pathogens in the sinus. According tosome embodiments, the lab on a chip may enable diagnosis of certainpathogens such as Staphylococcus Aureus. According to some embodiments,the lab on a chip may enable analysis of antibiotic resistance andenhanced diagnosis of certain pathogens such as Methicillin-ResistantStaphylococcus Aureus. According to some embodiments, the lab on a chipmay enable analysis of the bacterial diversity of commensal sinusbacteria or the presence of probiotic bacteria species.

According to some embodiments, the therapeutic or diagnostic device maymeasure: c-reactive protein measurement and or Erythrocyte sedimentationrate apparatus such as CRP or ERS strips, White BloodCells—WBC/Leucocytes indication for contamination, Neutrophils—NEUTindication for contamination, Lymphocytes—LYMPH/LYM indication for viralcontamination, Monocytes—MONO indication for viral contamination,Basophils—BASO, Eosinophils—EOSIN/EOS indication for allergy, PHlevel,Nitric oxide NO or Nitrogen Dioxide NO2, a2-macroglobulin (as a markerfor plasma contamination) lactoferrin (as a marker for glandularsecretion), lactate dehydrogenase (as a marker for tissue injury),interleukin (IL)-1b, IL-8, tumour necrosis factor-a, eosinophil cationicprotein and tryptase (as indicators for tissue inflammation), bacterialor other pathogens DNA sequencing, each option provides a separateembodiment.

According to some embodiments, the therapeutic or diagnostic device maycomprise a Radar. According to some embodiments, the Radar may enablethe user to map the sinus dimension and assist in locating the device'sdistal tip in the sinus space. According to some embodiments, the Radarmay enable the user to detect substructures in the sinus such as Tumors,Lesions, Polyps Nerves, Mucoceles, fungal ball and mucus deposits.According to some embodiments, the Radar may enable the user to positionthe rotating wire in a harmless location, such as to avoid nerves in thesphenoid sinus, or in a therapeutic location, such as in the center of afungal ball or mucus deposits.

According to some embodiments, the therapeutic or diagnostic device maycomprise an electric wire, to sense the presence and location of nervesin the sinus by the nerves electric pulse. The device might alsocomprise a Voltmeter and Ampere meter. For example, that way the usermight not harm the infraorbital nerve during maxillary sinus puncturing.

According to some embodiments, the therapeutic or diagnostic device maycomprise a solid state LIDAR (Light Detection And Ranging). According tosome embodiments, the LIDAR can be used to map the nasal and sinusescavities. According to some embodiments, the LIDAR may be used tonavigate the device in the nasal and sinuses cavities.

According to some embodiments, the therapeutic or diagnostic device maymeasure the sinus content resonance frequency. According to someembodiments, the resonance frequency measurement may identify themicrobes and bacteria in the sinus.

According to some embodiments, the therapeutic or diagnostic device maycomprise a grasper or, biopsy punch or other cutting device. Such adevice might enable mucosa or polyps samples to be taken for labanalysis.

According to some embodiments, the therapeutic or diagnostic device maycomprise a guidewire structure to assist the sinus penetration.According to some embodiments, the guidewire structure may have ahydrophilic cover. According to some embodiments, the guidewirestructure may be lubricated.

According to some embodiments, the therapeutic or diagnostic device maycomprise a piezoelectric crystal and electric wiring. According to someembodiments, the piezoelectric crystal vibration can be used to assistsinus lavage in mucus softening, or in reducing the viscosity of themucus, or by breaking mucus deposits, or by moving/stirring the lavageliquids. According to some embodiments, the vibration can be ultrasonicand it can be mediated via the lavage liquids. According to someadditional embodiments the piezoelectric crystal vibration can be usedto expand the sinus ostial diameter. The vibration may remove part ofthe liquids in the ostial mucosa, and expand ostial size.

According to some embodiments, the therapeutic or diagnostic device maycomprise a laser or heat source such as a monopolar for diathermy.According to some embodiments, it can be used for ablation of mucosa,such as polyps. According to some embodiments, it can be used to stopbleeding. According to some embodiments, the heat source is configuredto heat the sinus liquids or the irrigation liquids. According to someembodiments, the heat source is configured to heat the sinus liquids orthe irrigation liquids to more than about 20, 25, 30, 35, 37, 40° C.,each possibility represents a separate embodiment. According to someembodiments, heating can improve the patient's experience and reducediscomfort. According to some embodiments, heating can improve the mucusdissolvent speed. According to some embodiments, the therapeutic ordiagnostic device can comprise a thermometer. According to someembodiments, the thermometer may be used to verify that the device doesnot cause overheating of the tissue. According to some embodiments, theheat source and or thermometer may be located in the device syringe,within, around or near the liquid tube or the cannula coiling/braiding.

According to some embodiments, the therapeutic or diagnostic device maycomprise an absorbable material such as a gel, foam, a pad or a sponge.According to some embodiments, the absorbable material may be used bythe user to stop bleeding. According to some embodiments, the absorbablematerial may be filled with a drug. According to some embodiments, thedrug is a mucolytic, an anesthetic drug such as lidocaine or cocaine, adecongestant drug such as epinephrine, an antibacterial drug, aninflammatory drug, steroids, such as corticosteroids or a combination ofthe above-mentioned drugs, each possibility/combination represents aseparate embodiment. According to some embodiments, the drug can beeluted by pressing the absorbable material against the mucosa. Accordingto some embodiments, the drug can be eluted by the irrigation liquids.According to some embodiments, the drug can be eluted in the medialmeatus. According to some embodiments, the drug can be eluted in thesinus ostia. According to some embodiments, the drug can be eluted inthe sinus cavity. According to some embodiments, the drug elutingabsorbable material can be left within the sinus. According to someembodiments, the drug eluting absorbable material can be released fromthe device by liquid pressure. According to some embodiments, the drugeluting absorbable material can elute the drug over a period of morethan 1 day, more than 1 week, more than 1 month, more than 3 months,more than 6 months, more than 12 months, each option represents aseparate embodiment.

According to some embodiments, the therapeutic or diagnostic device maycomprise an expandable mechanism such as a balloon. According to someembodiments, the balloon backbiter or punch may be used to expand thesinus ostia. According to some embodiments, the balloon may be used tomeasure the sinus ostial size. According to some embodiments, the usercan inflate the balloon to a certain size and then pull it out of thesinus. This may provide the user an indication of the sinus ostial size.

According to some embodiments, the therapeutic or diagnostic device mayelectrify the liquids in the sinus. According to some embodiments, therotating wire or other wire can electrify the liquids in the sinus.According to some embodiments, the cannula can electrify the liquids inthe sinus.

According to some embodiments, all the above mentioned therapeutic ordiagnostic devices may be inserted into the sinus via the guiding tube.

According to some embodiments, a sinus/ear opening dilation apparatussuch as a balloon may be mounted over the cannula. According to someembodiments, such dilation apparatus may be configured to dilate a sinusopening or Eustachian tube. According to some embodiments, such dilationapparatus may be configured to dilate a sinus opening or Eustachian tubewhile the wire is rotating within the sinus/ear cavity. According tosome embodiments, such dilation apparatus may be configured to dilate asinus opening or Eustachian tube to facilitate the entry into a sinuscavity and/or sinus cleaning.

According to some embodiments, the syringe or the actuator or a devicepart that is connected to the syringe may have a pressure measurementmechanism. According to some embodiments, the pressure measurementmechanism may give the user indication regarding the pressure in thesyringe or in the device or in the sinus, each possibility represents aseparate embodiment. According to additional embodiments, the pressuremeasurement mechanism may give an indication of creation pressurethreshold. According to additional embodiments, the device can beconfigured to stop pressure increment or reduce the pressure overcreation pressure threshold. According to some embodiments, a valve,such as a spring based valve may reduce the pressure. According to someembodiments, the spring actuator may reduce the pressure or preventpressure increment.

According to some embodiments, the syringes may have seals to preventaspirated mucus from spilling out of the syringe after use. According tosome embodiments, the device kit may contain one or more syringe seals.According to some embodiments, the syringes may contain some of thepatient's samples. According to some embodiments, the syringes maycontain a sticker on which the user can write. According to someembodiments, the syringes may contain instructions or warnings, such asdo not use with drugs, drug warnings or drug instructions.

According to some embodiments, the device may contain more than onesyringe. According to some embodiments, the syringes may be connected tothe device by T or Y connector. According to some embodiments, thesyringes can be connected to a connector with more than three ports.According to some embodiments, some of the ports might have a one-wayvalve such as a duckbill valve. Such a valve may prevent backflow of gasor liquids from one syringe to the other. According to some embodiments,the syringes may contain a handle or a gunlock that will preventbackflow from one syringe to the other. According to some embodiments,the syringes may contain a syringe stop cock. According to someembodiments, the syringes may be safety syringes with maximal pressurelimitation. According to some embodiments, one syringe might be used forirrigation and another one for aspiration. According to someembodiments, the aspiration syringe is bigger than the irrigationsyringe. According to some embodiments, the device might contain morethan one syringe for more than one irrigation, at least one of thosesyringes containing a drug or therapeutic substance. According to someembodiments, the device might be used for a sequence of irrigations withdifferent drugs or therapeutic substances in separate syringes.

According to some embodiments, the syringes or at least part of theirrigation may contain a therapeutic substance, a drug, phage orbacteria for sinus wash. According to some embodiments, the drug orsubstance may be steroids, decongestants, analgesics, anesthetic,antibiotics, antibacterial substance, antiviral substance, antifungalsubstance, anti-inflammatory substance, mucolytic substance, surfactant,saline, hyperosmolar saline, acidic substance, basic substance, abrasivematerial, each possibility represents a separate embodiment.

According to some embodiments, there is provided a method to treatsinusitis: Step of removing mucus from the sinus by lavage using arotating/grinding wire to stir the lavage liquids. Step of filling thesinus with a drug. Step of washing antiseptics or drug or medicationfrom the sinus. Alternatively, this last step can be disabling of thedrug.

According to some embodiments, there is provided a method to treatsinusitis: Step of removing mucus and bacteria from healthy sinus bylavage using a rotating/grinding wire to stir the lavage liquids. Stepof removing mucus from not healthy sinus by lavage using arotating/grinding wire to stir the lavage liquids. Step of filling theunhealthy sinus with mucus and bacteria from the healthy bacteria.According to some embodiments, the healthy sinus can be of the samepatient, or it can be a sinus of a different patient. According to someembodiments, the last step can comprise insertion of a sustained releasedrug into the sinus.

According to some embodiments, provided is a method to treat sinusitis:Step of removing mucus and bacteria from healthy sinus by lavage using arotating/grinding wire to stir the lavage liquids. Step of removingmucus from unhealthy sinus by lavage using a rotating/grinding wire tostir the lavage liquids. Step of filling the unhealthy sinus with atherapeutic agent, antiseptic, medication or other drug. Step of washingthe therapeutic agent, antiseptic, medication or other drug or from theunhealthy sinus. Alternatively, this last step can be disabling of thedrug. Step of filling the unhealthy sinus with mucus and bacteria fromthe healthy bacteria. According to some embodiments, the healthy sinuscan be of the same patient, or it can be a sinus of a different patient.According to some embodiments, the last step can comprise insertion of asustained/ controlled release drug into the sinus.

According to some embodiments, the methods can comprise the step ofsending the mucus to a lab. According to some embodiments, the methodscan comprise a step of healthy sinus bacteria diagnosis. According tosome embodiments, the methods can comprise a step of unhealthy sinusbacteria diagnosis. According to some embodiments, bacteria diagnosiscan influence a treatment decision, such as using or not using theaspirated mucus or using an additional drug. According to someembodiments, the methods can comprise additional steps of using anadditional therapeutic agent, antiseptic, medication or other drug, andadditional steps of lavage.

According to some embodiments, the therapeutic substance, drug, phage orbacteria may be instilled within a carrier's medium or a vehicle.According to some embodiments, the carrier's medium or vehicle providessustained or controlled release to the therapeutic substance, drug,phage or bacteria. According to some embodiments, the medium or vehiclemay be a gel, a foam, an aerosol, an emulsion, a suspension, anadhesive, or other capsulation mechanisms, all in separate embodiments.According to some embodiments, the medium or vehicle of the therapeuticsubstance, drug, phage or bacteria may be injected into the sinus.According to some embodiments, the medium or vehicle of the therapeuticsubstance, drug, phage or bacteria may be injected into the sinus duringor after sinus lavage. According to some embodiments, the medium orvehicle may release the therapeutic substance, drug, phage or bacteriawithin the sinus for a period of more than one day, one week, one month,one quarter, one year all in separate embodiments. According to someembodiments, the medium or vehicle may resist the sinus mucosalclearance, and sustain in the sinus for a period of more than one day,one week, one month, one quarter, one year all in separate embodiments.According to some embodiments, the medium may change its propertiesafter being inserted into the sinus. According to some embodiments, themedium may increase its resistance to flow, its viscosity, itsadhesiveness its rigidity, or solidify, after being inserted into thesinus. For example, according to one embodiment, the drug medium isliquid during insertion within the syringe and cannula, but itsolidifies to foam within the sinus, by the body temperature. Accordingto some embodiments, the medium can control the release of thetherapeutic substance into the sinus cavity by exterior stimuli, such asRF radiation.

According to some embodiments, the carrier's medium or a vehicle may besuitable to provide bacteria a supportive environment. According to someembodiments, the carrier's medium or a vehicle may be suitable toprovide agar and nutrition to bacteria. According to some embodiments,the carrier's medium or a vehicle may be suitable to provide asupportive environment to creation bacteria, that is not supportive toother kinds of bacteria. According to some embodiments, the carrier'smedium or a vehicle can comprise selective growth factors, such asoxygen enrichment, proteins, pH level or sugars. According to someembodiments, the carrier's medium or a vehicle may be or have theproperties of healthy nasal/sinus mucus. According to some embodiments,the carrier's medium or a vehicle may be healthy nasal/sinus mucusdiluted with saline or water.

According to some embodiments, the above-mentioned bacteria, bacterialsupplement, bacterial interference, bacterial treatment or probioticmight include: viridans streptococci, α-Streptococcus: Alpha-hemolytic,Pneumococci, The S. viridans group: alpha-hemolytic, Beta-hemolytic,enterococci streptococci, streptococci, streptococci, Aerobicalpha-hemolytic streptococci (such as Streptococcus mitis andStreptococcus sanguis) or nonhemolytic such as Ab1III. Streptococcusoralis Parker and S. oralis, Prevotella melaninogenica,Peptostreptococcus sp, anaerobius, Nonhemolytic streptococci,Corynebacterium spp. Such as (Co304), Corynebacterium such asCorynebacterium sp (API Coryne bioprofile; 5100304), Prevotella sp,Staphylococcus aureus such as 502A of S. Aureus, Coagulase-negativestaphylococcus, Staphylococcus epidermidis, Streptococcus salivarius,Streptococcus mutans, Enterococcus faecalis, Streptococcus pneumoniae,Streptococcus pyogenes, Neisseria sp., Neisseria meningitidis,Enterobacteriaceae (Escherichia coli), Proteus sp., Pseudomonasaeruginosa, Haemophilus influenzae, Haemophilus spp, Lactobacillus sp.,Clostridium sp, Corynebacteria, Mycobacteria, Actinomycetes,Spirochetes, Mycoplasmas, S. agalactiae, S. anginosus, S. bovis, S.canis, S. constellatus, S. dysgalactiae, S. equinus, S. iniae, S.intermedius, S. milleri, S. mitis, S. mutans, S. oralis, S.parasanguinis, S. peroris, S. pneumoniae, S. pseudopneumoniae, S.pyogenes, S. ratti, S. salivarius, S. tigurinus, S. thermophilus, S.sanguinis, S. sobrinus, S. suis, S. uberis, S. vestibularis, S.viridians, S. zooepidemicus, Corynebacteria, Cardiobacterium spp,Eikenella corrodens, Kingella spp, Kingella kingae, Moraxella spp,Moraxella catarrhalis, Mycoplasma pneumoniae, Neisseria spp, Neisseriacinerea, Neisseria lactamica, Neisseria meningitides, Neisseria mucosa,Neisseria sicca, Peptococcus spp, Selenomonas sputigena, Streptobacillusspp, Streptococcus mitis, Streptococcus pyogenes, together or separatelyas different embodiments.

According to some embodiments, the dug may include Acesulfame K,Acetamide MEA (monoethanolamine), Acetic acid, Activated charcoal,African palm oils, Alcohol, Alcohol (ethyl alcohol), Allantoin, Almondmeal, Aloe vera, Aluminum hydroxide, Aluminum magnesium hydroxidestearate, Aluminum oxide, Aluminum pigment, Aluminum sulfate, Ammoniumphosphate, Angelica sp., Aqueous wheat extract, Arachidyl alcohol,Ascorbyl palmitate (Vitamin C ester), Ascorbyl tetraisopalmitate(Vitamin C ester), Avocado oil, Bacitracin, Beeswax, Behenyl alcohol(docosanol, Abreva), Benzalkonium cetyl phosphate, Benzalkoniumchloride, Benzocaine, Benzoic acid, Benzyl alcohol, Betaines (variousforms), Bisabolol (chamomile oil), Bismuth subgallate, Bismuthtribromophenate, Borneol, Butylated Hydroxytoluene (BHT), Butyleneglycol, Butyrospermum parkii, Cadexomer iodine, Calamine, Calcium,Calcium carbonate, Calcium chloride, Calcium oxide, Calcium sulfate,Camelia sinensis, Candelilla wax, Capryloyl glycine, Carvacrol, Centellaasiatica, Ceramide, Ceteareth-10 phosphate, Cetearyl alcohol(Cetostearyl alcohol), Ceteth-20, Cetyl alcohol, Cetyl dimethiconecopolyol, Cetyl palmitate, Cetylpyridinium chloride, Chlorhexidine,Chlorhexidine gluconate, Chlorine dioxide, Chlorophyllin copper complexsodium, Cholesterol, Chromium chloride, Citric acid, Citris grandisextract, Cloflucarban, Cobalt chloride, Cocoamphodiacetate, Colloidalsilica, Combination of potassium vegetable oil, solution, phosphatesequestering agent, and triethanolamine, Conjugated linoleic acid,Copper, Copper chloride (cupric chloride), Crystal violet, Cupuacubutter, Cyclodextrin, Cyclomethicone, DEA Cetyl phosphate, Decanoic acid(capric acid), Dehydroacetic acid, Dialkyl carbamoyl chloride,Diazolidinyl urea, Dicetyl phosphate, Diisopropyl adipate, Dimethicone,Dipolyhydroxystearate, Dissolved oxygen, DMDM hydantoin, EDTA, Ethanol,Ethoxydiglycol, Ethylene glycol monostearate, Ethylhexyl glycerin,Ethylhexyl palmitate, Eucalyptus oil, Eugenol, Extracts of licorice(deglycyrrhizinated), Ferric chloride Hexahydrate, Ferric oxide,Fluorosalan, Fruit extract, Fumed silica, Gentian violet, Germaben II,Glycerin (glycerol) ,Glyceryl monolaurate, Glyceryl monostearate,Glyceryl stearate, Glycyrrhetinic acid (licorice extract), Guar gum(Cyaiuopsis letragonolobus), Gum mastic, Hectorite clay,Hexachlorophene, Hexyl laurate ,Hydrochloric acid, Hydrocortisone,Hydrogen peroxide, Hydrogenated castor oil, Hydrogenated lecithin,Hydroquinone, Hydrous lanolin, Hydroxypropyl bispalmitamideMEA,)ceramide(, Hydroxypropyl guar, Hypochlorous acid, Iodine, Iodinecomplex (ammonium ether sulfate, and polyoxyethylene sorbitan,monolaurate(, Iodine complex (phosphate ester of, alkylaryloxypolyethylene glycol, Iodoform, Iodophors (Iodine-containingingredients), Iron (various forms), Iron sulfate, Isohexadecane,Isopropyl alcohol, Isopropyl alcohol, Isopropyl myristate, Isopropylsorbate, Kaolin, Karaya gum, Keratin, Konj ac flour, Lactic acid,Lavender, Lecithin, Lemon, L-glutamic acid, Lidocaine, Light mineraloil, Liquid Germall Plus (propylene glycol, diazolidinyl urea,iodopropynyl, butylcarbamate(, Lyophilized formulate porcine plasma,Magnesium aluminum silicate, Magnesium oxide, Magnesium stearate,Magnesium sulfate, Malic acid, Maltodextrin, Manganese chloride,Manganese oxide, Mannitol, Meadowsweet extract. Menthol, Methylsalicylate, Methyl triethoxysilane (MTES), Methylal, Methylbenzethoniumchloride, Methylene blue, Mineral oil, Molybdenum chloride, Myristylmyristate, Myrtillus extract, Nonylphenoxypoly (ethyleneoxy),Ethanoliodine, Oak extract, Oat glucan, O-cymen-5-ol (Biosol), Oliveoil, Ozone, Palm glycerides, Palmitamide MEA, Palmitic acid, PanthenolFCC (form of vitamin B), Parabens (various forms), Paraffin ,Pentalyn-H(Pentaerythritol ester of rosin), Pentylene glycol, Petrolatum, Phenol(greater than 1.5 percent), Phenol (less than 1.5 percent),Phenoxyethanol, Phosphoric acid, Phosphorus pentoxide, Piroctoneolamine, Poloxamer—iodine complex, Polyaminopropyl biguanide (PAPB),Polygonum cuspidatum, Polyhexamethylene biguanide, Polyhexamethylenebiguanide (PHMB—polyhexanide(, Polymyxin B sulfate, Polyricinoleate,Polyvinyl pyrrolidone-iodine, Potassium ferrate, Potassium iodide,Potassium iron oxyacid salt, Potassium sorbate, Povidone iodine,Povidone USP (Plasdone K 29-32), Povidone-iodine 5 to 10 percent, Propylgallate, Propylene glycol, Pyroglutamic acid, Quaternium 15, RADA-16peptide, Rubidium chloride, Saccharin, Salicylic Acid, Salicylic acid,Sandalwood oil, Sarcosine, Secondary amyltricresols, Shea butter, Silver(various forms), Silver sulfadiazine, Sodium benzoate, Sodium citrate,Sodium fluoride, Sodium hypochlorite, Sodium lactate, Sodiummetabisulfite, Sodium oxychlorosene, Sodium selenite, Sodium sulfate,Sodium tetraborate (Borax), Solanum lycopersicum (tomato) extract,Sorbic acid, Sorbitan sesquioleate (Arlacel C), Sorbitol, Soy protein,Squalane, Steareth-10, Stearic acid, Styrax, Sucralfate (sucroseoctasulfate, aluminum, hydrochloride), Sucrose, Sucrose laurate, Sulfur, dioxide, Tara Gum, Tartaric acid, Tea tree oil, Tea tree oil,Telmesteine, Theobroma Grandiflorum seed butter, Thrombin, Thymol,Titanium dioxide, Titanium oxide, Tonalin FFA 80, Transcinnamaldehyde,Tribromsalan, Triclocarban, Triclosan, Triethanolamine (TEA),Triglycerol (polyglycerol-3), Triiodide resin, Triple dye, Trolamine,Tromethamine USP, Undecoylium chloride iodine complex, Vaccinium(blueberry), Vegetable oil, Vitamin C (ascorbic acid), Vitamin E(tocopherol), Vitis vinifera (grape), White petroleum, Wintergreenfragrance, Wood pulp core, Xanthan gum, Xylitol, Zinc (various forms),Zirconium oxide, Azithromycin, Levofloxacin, Ciprofloxacin Neo/Poly/DexTobramycin Dexamethasone, Azelastin, Prednisolone, Olopatadine, Garlic,Carvacrol, Olive/ Olive leaves extracts, Turmeric, Echinacea, Ginger,Goldenseal, Oregano Oil, Cayenne Pepper, Colloidal Silver, GrapefruitSeed Extract, Manuka Honey, Pau d′Arco, Neem, Turmeric, Pau D′arco,Apple Cider Vinegar, Grapefruit Seed Extract, Virgin Coconut Oil,Mepolizumab (IL-5 antagonist), Montelukast, Doxycycline, together orseparately as different embodiments.

According to some embodiments, the user may use only one component ofthe above stated substances during or after sinus lavage. According tosome embodiments, the user may use more than one component of the aboveduring or after sinus lavage. According to some embodiments, the usermay use more than one component of the above during or after sinuslavage in more than one sinus lavage. For example, the user may lavagethe sinus with saline and steroids, and only then lavage it again withbacteria and steroid gels.

According to some embodiments, the abrasive material contains small hardparticles. According to some embodiments, the abrasive material mayincrease mucosa, polyps, bacteria and biofilm removal from the sinuswall. According to some embodiments, the abrasive material may beinserted into the sinus within gas or liquid. According to someembodiments, the abrasive material may dissolve, degrade and or beevacuated from the sinus after lavage. Most abrasive materials such assilica might cause harm to the sinus and nasal mucosa, unless it isremoved. According to some embodiments, the abrasive material may be asalt. According to some embodiments, the abrasive material may bemagnesium such as magnesium oxide.

According to some embodiments, all the above can be inserted into thesinus via another mechanism instead of a syringe, such a capsule orirrigation machine, during or after sinus lavage.

According to some embodiments, the syringes or other aspirated materialcavity or capsule, may contain a medium for bacterial growth, such as amedium for aerobic or anaerobic bacteria.

According to some embodiments, the syringes, other aspirated materialcavity or capsule, may contain a pH measurement apparatus, such as pHlitmus paper. According to some embodiments, the device kit may containpH measurement equipment such as pH litmus paper. According to someembodiments, the user may use the pH level to distinguish betweenaerobic or anaerobic bacteria. The user may change the medium forbacterial growth and the treatment accordingly. For example, he may usedifferent antibiotics and bacteria supplements.

According to some embodiments, the syringes, other aspirated materialcavity or capsule, may contain a c-reactive protein measurement and orErythrocyte sedimentation rate apparatus such as CRP or ERS strips.According to some embodiments, the device kit may contain a c-reactiveprotein or Erythrocyte sedimentation rate measurement apparatus such asCRP or ERS strips, and method embodiments the user may change thetreatment according to those measurements. For example, he may usedifferent antibiotics, and bacteria supplements.

According to some embodiments, and method embodiments the syringes orkit might include also the use of measurement for one or more of thefollowing: White Blood Cells—WBC/Leucocytes indication forcontamination, Neutrophils—NEUT indication for contamination,Lymphocytes—LYMPH/LYM indication for viral contamination, Monocytes—MONOindication for viral contamination, Basophils—BASO,Eosinophils—EOSIN/EOS indication for allergy, a2-macroglobulin (as amarker for plasma contamination) lactoferrin (as a marker for glandularsecretion), lactate dehydrogenase (as a marker for tissue injury),interleukin (IL)-1b, IL-8, tumour necrosis factor-a, eosinophil cationicprotein and tryptase (as indicators for tissue inflammation) together orseparately as different embodiments.

According to some embodiments, the device and method might include atleast one of the following bacteria diagnostic measures in the syringeor in other cavity: PHmeasurement, Electrical conductivity, Resonancefrequency, Mass spectrometry, Spectroscopy, Bacterial DNA sequencing,and culture growing, Antibiogram, together or separately as differentembodiments.

According to some embodiments, the measurements might include NitrogenDioxide NO2 Gas measurement such as with Dioxide NO2 Gas Analyzer.According to some embodiments, the measurements might include Nitricoxide NO Gas measurement such as with Chemiluminescence or NIOX Mino.According to some embodiments, the measurements might include artificialnose measurement or other apparatus that identify bacteria, cell,pathogens or its product in molecules in aspirated gas from the sample.

According to some method embodiments, the user might use the abovementioned measurements to make a decision whether the aspirated samplecontains bacteria, fungi viruses, or no pathogen. According to somemethod embodiments, the user might use the above mentioned measurementsto make a decision whether the aspirated sample contains aerobic oranaerobic bacteria. According to some method embodiments, the user mightuse the above mentioned measurements to make a decision on the mostappropriate treatment. According to some method embodiments, the usermight use the above mentioned measurements to make a decision on themost appropriate antibiotic treatment. According to some methodembodiments, the user might use the above mentioned measurements to makea decision on the most appropriate bacterial supplement. According tosome method embodiments, the user might use the above mentionedmeasurements to make a decision on the most appropriate allergytreatment.

According to some embodiments, all the above can be extracted out of thesinus via another mechanism instead of a syringe, such as an aspirationmachine and be processed in a capsule or other container.

According to some embodiments, provided is a method to treat sinusitis:Step of removing mucus from the sinus by lavage using arotating/grinding wire to stir the lavage liquids. Step of filling thesinus with antiseptics or drug or medication to reduce microorganismconcentration in the sinus. Step of washing antiseptics or drug ormedication from the sinus. Alternatively, this last step can bedisabling the antiseptics or drug or medication.

Antiseptics and Bactericidal may include: Alcohols, or “surgicalalcohol” such as ethanol (60-90%), 1-propanol (60-70%) and2-propanol/isopropanol (70-80%) or mixtures of these alcohols.Surfactants. Anionic, or zwitterionic surfactants. PEG-80 Sorbitanlaurate, Cocamidopropyl betaine, and Sodium Trideceth Sulphate (Johnson& Johnson Baby Shampoo). Citric acid such as Zwitterionic SurfactantCationic surfactants such as quaternary ammonium cations such asbenzalkonium chloride 0.05-0.5%, chlorhexidine 0.2-4.0% or octenidinedihydrochloride 0.1-2.0%, Chlorhexidine gluconate. Quaternary ammoniumcompounds, (quats or QACs), such as, cetyl trimethylammonium bromide,cetylpyridinium chloride, and benzethonium chloride. cetyltrimethylammonium chloride, didecyldimethylammonium chloride and others,non-quaternary compounds, such as chlorhexidine, glucoprotamine,octenidine dihydrochloride etc. Chlorhexidine and Octenidine. Boricacid. Brilliant green (triarylmethane dye). Hydrogen peroxide such as 6%or lower. peracetic acid (Hydrogen peroxide and acetic acid). Iodinesuch as: Tincture of iodine/Lugol's iodine (Iodine & alcohol. 1% iodineor less. iodinated nonionic surfactants), Povidone-iodine (an iodophor,complex of povidone, a water-soluble polymer, with triiodide anions I3—,containing about 10% of active iodine). Manuka honey. MercurochromeOrganomercury antiseptics such as bis-(phenylmercuric)monohydrogenborate (Famosept). Octenidine dihydrochloride. (0.1-2.0%).Octenidine. Chlorhexidine. 1&2-phenoxyethanol. Phenolic substances suchas Phenol, cresols, TCP, Lysole. halogenated (chlorinated, brominated)phenols, such as hexachlorophene, triclosan, trichlorophenol,tribromophenol,pentachlorophenol, Dibromol and salts thereof. thymol,hexachlorophene, triclosan, and sodium3,5-dibromo-4-hydroxybenzenesulfonate (Dibromol). Polyhexanide(polyhexamethylene biguanide, PHMB). Sodium chloride (salt) Sodiumhypochlorite boric acid. Calcium hypochlorite. Sodium bicarbonate(NaHCO3). Balsam of Peru. Xylitol. Chlorine such as hypochlorites,chloramines, dichloroisocyanurate and trichloroisocyanurate, wetchlorine, chlorine dioxide. Active oxygen and peroxides, such asperacetic acid, potassium persulfate, sodium perborate, sodiumpercarbonate, and urea perhydrate. oxidizers, such as ozone andpermanganate solutions. acids such as phosphoric, nitric, sulfuric,amidosulfuric, toluenesulfonic acids. Alkalis such as sodium, potassium,calcium hydroxides. Tea tree oil.

According to some embodiments, Antimicrobial may be NanomaterialsAntimicrobial or Nanoparticles, (i.e., metal, metal oxide, and organicnanoparticles). According to some embodiments, antibacterialNanomaterials interact electrostatically with the bacterial membranecausing membrane disruption.

Inorganic Nanoparticles includes Metal oxide nanoparticles such assilver (Ag), iron oxide (Fe3O4), Superparamagnetic Iron Oxide, titaniumoxide (TiO2), copper oxide (CuO), zinc oxide (ZnO), Magnesium oxide(MgO) as MgX2, MgF2, Nitric oxide (NO) nanoparticles, Polyethylenimineand quaternary ammonium compounds, Chitosan & polyguanidines, AluminumOxide.

Organic Nanoparticles includes: Poly-ϵ-lysine, Quaternary AmmoniumCompounds, Cationic Quaternary Polyelectrolytes, N-Halamine Compounds,Polysiloxanes, Benzoic Acid, Phenol, and p-Hydroxy Benzoate Esters,Quaternary Phosphonium or Sulfonium, Triclosan,5-Chloro-8-hydroxy-quinoline, Peptides, Organometallic Polymers,Polymeric Nanosized Antimicrobials, Polycationic Nanoparticles,Chitosan.

According to some embodiments, the device comprises a needle capable ofpuncturing the sinus wall. According to some embodiments, the needle isstraight and, according to some embodiments, it is a curved needle.According to some embodiments, the device's needle is mounted on part ofthe device distal tip. According to some embodiments, the device'sneedle is mounted on the tubular guide or bent tube. According to someembodiments, the device's needle is the tubular guide or bent tube (theneedle is replacing the tubular guide or bent tube). According to someembodiments, the device needle is the extension of the tubular guide orbent tube. According to some embodiments, the device's needle isstraight and, according to others, it is bent. According to someembodiments, the device needle is capable of containing at least some ofthe cannula. According to some embodiments, the device's needle ismounted on the tubular guide or bent tube from within it. According tosome embodiments, the device's needle is mounted on the cannula.According to some embodiments, the device's needle is the cannula (theneedle is replacing the cannula). According to some embodiments, thedevice's needle is the extension of the cannula. According to someembodiments, the device's needle is capable of containing at least someof the grinding wire. According to some embodiments, the bent tube isinserted into the sinus after needle puncture. According to someembodiments, the bent tube is inserted into the sinus after needlepuncture. According to some embodiments, the cannula is inserted intothe sinus after needle puncture. According to some embodiments, thecannula distal tip bends or changes its orientation within the sinusafter being inserted. According to some embodiments, the grinding wireis inserted into the sinus after needle puncture. According to someembodiments, the wire distal tip bends or changes its orientation withinthe sinus after being inserted.

According to some embodiments, the needle is inserted into the sinus,the wire is inserted into the needle, the irrigation liquids areinserted and or aspirated via the needle, and the guiding tube thatsurround the cannula aspirates the spilled liquids of the puncturedopening.

According to some embodiments, the device needle has the diameter of 3mm, as a conventional cannula. According to some embodiments, the deviceneedle has the diameter of equal or less than 3 mm According to someembodiments, the device needle has the diameter of equal or less than 2mm According to some embodiments, the device needle has the diameterequal or less than 1 mm As in the small diameter cannula descriptionabove, the grinding wire enables reduction of the mucus viscosity andthus facilitate suction via smaller diameter than typically appliedtoday. Using smaller diameter puncturing might enable faster mucosalrecovery and might cause less complications such as pain, bleeding,contamination, or neural puncturing. Safer puncturing may be importantin cases, which the user finds it difficult to find the natural sinusopening or penetrate it. According to some embodiments, the sinuspuncturing is not limited to the maxillary and sphenoid sinuses but italso can be used to puncture every nasal cavity or head sinus, such asthe ethmoid sinus cells, the ethmoid bola, the mastoid sinus, the middleear, etc.

According to some embodiments, the device needle can be advanced forwardand into the sinus wall by unlashing a tensed spring. According to someembodiments, the distance of the needle movement forward and into thesinus wall is limited by a stopper or a restraining mechanism. Accordingto some embodiments, the distance is less than 20 mm, 10 mm, 5 mm, 3 mm,2 mm, all in separate embodiments. The mechanism may assist the user toavoid over penetration into the sinus. Orbital puncturing duringmaxillary sinus puncturing is a rare but very disturbing complication,well documented in the literature.

According to some embodiments, the device's needle can be advancedforward and into the sinus wall by the cannula handle. According to someembodiments, the device's needle can be advanced forward and into thesinus wall by a motor. According to some embodiments, the device'sneedle can be advanced forward and into the sinus in screwing motion.According to some embodiments, the device's needle has threading.According to some embodiments, the device's needle has a drill in a tubeshape, that is surrounding the cannula or the grinding wire. Accordingto those embodiments, the cannula or the grinding wire is inserted intothe sinus cavity after the drill is drilled into the sinus. According tosome embodiments, the device's drill or the device's needle is pushedinto the sinus wall with a pneumatic hammer mechanism.

According to some embodiments, the cannula can be detached from thedevice and stay within the sinus for further lavages or as drains.According to some embodiments, the threaded needles can be detached fromthe device and stay within the sinus for further lavages or as drains.According to some embodiments, the cannula or threaded needles can bereattached to the device. According to those embodiments, a new wire canbe inserted into the cannula for additional mucus stirring and grindingduring irrigation and aspiration.

According to some embodiments, the cannula and/or guiding tube and orgrinding wire may be inserted into a sinus via the sinus wall or via thesinus floor. According to some embodiments, the cannula and/or guidingtube and or grinding wire can be inserted into a maxillary sinus cavityvia a molar tooth or via a tooth hole, or via patient gum (as theancient Egyptians drained the maxillary sinuses). According to someembodiments, the grinding wire can rotate within the sinus to grindmucus and or mucosa and or polyps.

According to some embodiments, the device may comprise an additionalhandle (endoscope grasping handle) that enables the user to grasp thehandle and an endoscope with the same hand. According to someembodiments, the handle may be attached to the device casing with a snapmechanism.

Throughout the following description, similar elements of differentembodiments of the device are referenced by element numbers differing byinteger multiples of 1000. For example, a device of FIG. 1 is referencedby the number 1000, and a device of FIG. 2, which corresponds to device1000 of FIG. 1, is referenced by the number 2000. For another example, aguiding tube of FIG. 1 is referenced by the number 1602, and a guidingtube of FIG. 2, which corresponds to guiding tube 1602 of FIG. 1, isreferenced by the number 2602.

Reference is now made to FIG. 1A and 1B which schematically illustrate adevice 1000 that may be used for treating a paranasal sinus condition ina retracted and opened configurations, respectively, according to someembodiments.

Device 1000 includes a guiding tube 1602 configured for insertion into asubject's nose such that a distal end thereof faces the subject'sostium; a flexible hollow cannula (“cannula”) 1600 at least partiallyhoused within guiding tube 1602 and movable therein such as to protrudedistally therefrom and intrude through the ostium into a sinus cavity ofthe subject; and a flexible wire 1614 at least partially housed withincannula 1600 and configured to move therein such as to protrude distallytherefrom into the sinus cavity and to grind, chop and/or stir materialpresent in the sinus cavity and/or inside cannula 1600.

Device 1000 may further include a distal casing section 1605, and aproximal casing section (which may also be referred to as housing) 1611.

Guiding tube 1602 includes a distal end 1601 shaped for insertion into anostril of a patient. Optionally, distal end 1601 is at least partiallybendable such as to face a natural opening of a paranasal sinusfollowing insertion to the nostril. Alternatively or additionally,distal end 1601 may be bent/curved. According to some embodiments,distal end 1601 is bendable by the user (for example by the user'shands). According to some embodiments, distal end 1601 is bendable usinga bending jig (not shown).

Optionally, the bend/curve is shaped such as to allow/facilitateinsertion of distal end 1601 into a sinus of a patient. Optionally, theinsertion is into a maxillary sinus, a frontal sinus, a sphenoid sinus,or Eustachian tubes. Each possibility represents a separate embodiment,and may be combined at will. In a non-limiting example, distal end 1601may be bent according to a desired application such as to an angleranging from 70 to 110 degrees for insertion into the maxillary sinus,an angle ranging from 0 to 30 degrees for insertion into the sphenoidsinus, an angle ranging from 60 to 80 degrees for insertion to thefrontal sinus, an angle ranging from 30 to 70 degrees for insertion intothe eustachian tubes.

Optionally, guiding tube 1602 having a distal end 1601 with a predefinedbend of a desired angle may be releasably applied to device 1000according to a desired insertion target (e.g., a maxillary sinus, afrontal sinus, a sphenoid sinus or eustachian tubes). Optionally,guiding tube 1602 is releasably connected to distal casing section 1605of device 1000, with one or more connectors selected from connector 1603and connector 1604. Optionally, one or more connectors 1603 and 1604 fixguiding tube 1602 in a selected orientation. Suitable connector typesinclude but are not limited to luer lock connector. According to someembodiments, the connection of guiding tube 1602 to distal casingsection 1605 is sealed to air and liquid flow.

Optionally, guiding tube distal end 1601 includes an atraumatic tip (notshown) such as having a smooth surface, a round or a ball shape.Optionally distal end 1601 includes one or more openings for irrigationand or aspiration. According to some embodiments, a lens, a lightsource, a camera or any combination thereof may be contained within ormounted on distal end 1601.

Optionally, cannula 1600 is operably connected to a cannula handle 1607.Optionally, cannula handle 1607 is operated to move cannula 1600 withinguiding tube 1602 proximally and distally, and optionally (asdemonstrated in FIG. 1B) to protrude distally from tubular member distalend 1601. Optionally, visual distance indications 1606 are marked ondistal casing section 1605. Those marks give the user visual feedbackabout cannula 1600 position. According to some embodiments, these marksmay indicate to the user whether the cannula was inserted into a sinusopening (and optionally, how far along) or not. Optionally, cannulahandle 1607 includes and is controlled by a trigger 1608 which movescannula 1600 back and forward when pressed on, and prevents movementwhen it is not pressed. Suitable mechanism for controlling cannulamovement may include, but is not limited to, a ratchet lock. Accordingto some embodiments, cannula handle 1607 and/or trigger 1608 provide theuser tactile feedback from cannula's 1600 distal tip 1629, via thecannula actuation mechanism. According to some embodiments, such tactilefeedback may indicate the user whether the cannula was inserted into asinus opening, or whether the cannula is being pushed into undesiredlocation, or whether the cannula is pushed in undesired force (such aspushed to strongly, which might cause injury).

Device 1000 may further include a gripper 1609, coupled to proximalcasing section 1611. Gripper 1609 is intended to be held by one hand ofa user (such as a doctor, nurse or a technician), optionally in a pencillike grip, or a gun like grip and is designed accordingly. Optionally,the gripper has a length ranging from 5 centimeters (cm) to 50 cm, 5 cmto 40 cm, 5 cm to 30 cm, 5 cm to 25 cm, 5 cm to 20 cm, 5 cm to 18 cm, 5cm to 15 cm, 8 cm to 50 cm, 8 cm to 40 cm, 8 cm to 30 cm, 8 cm to 25 cm,8 cm to 20 cm, 8 cm to 18 cm, 8 cm to 15 cm, 10 cm to 25 cm, 10 cm to 25cm, 10 cm to 20 cm, 10 cm to 18 cm, or 10 cm to 15 cm. Each possibilityrepresents a separate embodiment of the present invention. Gripper 1609may include a distal gripper 1609 a and proximal gripper 1609 b enablingthe user to hold gripping handle 1609, such that two, three or fourfingers of a hand may conveniently interface with a distal surface ofdistal gripper 1609 a and a thumb of a hand may conveniently interfacewith a proximal surface of proximal gripper 1609 b. Optionally, theindex finger of the hand may be fitted to and operate trigger 1608 ofcannula handle 1607. According to some embodiments, gripping handle 1609is designed to hold a syringe 1610 between distal gripper 1609 a andproximal gripper 1609 b, or other irrigation/ aspiration line other thansyringe 1610, such as a tube, a pump or a combination thereof.Optionally, this design is further utilized to prevent the user fromusing unintended syringe such as too big syringe by miss fittingunintended syringe geometric properties. According to some embodiments,gripper 1609 may enable the user to hold gripping handle 1609, such thatone, two or three fingers of a hand may conveniently hold syringe 1610.

Device 1000 may further include a wire handle 1612. Wire handle 1612 isoperably connected to wire 1614 and configured to move wire 1614 withincannula 1600 and optionally, protrude therefrom. According to someembodiments, wire handle 1612 or housing 1611 includes visual marks 1612a marked on an outer surface thereof to allow the user visual feedbackabout wire 1614 position in space. Wire handle 1612 may be coupled to amotor 1613 operably connected to wire 1614 (e.g., via a shaft such asshaft 3615, shown in FIG. 3A) and configured to rotate wire 1614 in highspeed. Optionally, motor 1613, is at least partially housed within wirehandle 1612. According to some embodiments, after attachment of themotor 1613 to the device, the motor 1613 itself may serves as a wirehandle instead of wire handle 1612. According to these embodiments, themotor is functionally connected to the wire 1614 (e.g., via a shaft suchas shaft 3615, shown in FIG. 3A) and is configured to move back andforth within casing 1611 as it advances/retrieves wire 1614. Accordingto some embodiments, wire handle 1612 and casing 1611 comprises rails1675 for orientation and smooth movement of handle 1612 within casing1611. According to some other embodiments, motor 1613 (which mayfunction as a handle as well as a motor) and casing 1611 comprise rails1675 for orientation and smooth movement of motor 1613 within casing1611. Referring to FIG. 1B, each of cannula handle 1607 and wire handle1612 is in an advanced position such that cannula 1600 protrudesdistally from distal end 1601 of guiding tube 1602, and wire 1614protrudes out (distally) of cannula 1600. Optionally, wire 1614protrudes out of a side wall of cannula 1600. Optionally, uponprotrusion from distal end 1601, cannula 1600 assumes a predefined shapeconfigured to reach a treatment area within a paranasal sinus.Optionally, a distal portion of cannula 1600 is curved or bent.

Optionally, distal tip 1629 of cannula 1600 may be an atraumatic tip(not shown) such as having a smooth surface, a round or a ball shape.Optionally, distal tip 1629 may include one or more openings forirrigation and or aspiration. Optionally, at least a portion of theopenings may be side firing apertures (holes). According to someembodiments, distal tip 1629 of cannula 1600 may be closed. According tosome embodiments, distal tip 1629 of cannula 1600 may include a taperthat direct wire 1614 towards the side-firing apertures. According tosome embodiments, a guide wire, a lens, a light source, a camera or anycombination thereof may be contained within or mounted on distal tip1629. According to some embodiments, a camera in distal tip 1629, may bedirected towards the rotating wire 1614 area. According to someembodiments, distal tip 1629 of cannula 1600 may have a pre-shaped bend.According to some embodiments, the bend may be about or less than 50, or40, or 30 or 20 or 10 degrees. Each possibility represents a separateembodiment of the present invention.

Reference is now made to FIGS. 2A and 2B, which show a device 2000 thatmay be used for treating a paranasal sinus condition in a retracted andan open configurations, respectively, according to some embodiments.Device 2000 is substantially similar to device 1000 described in FIGS.1A-B with the notable difference that device 2000 further includes acannula rotating mechanism 2635 operatively coupled to a flexible hollowcannula (“cannula”) 2600 of device 2000 to induce precession thereof.

Similarly to device 1000 of FIGS. 1A-B, device 2000 may include a distalcasing section 2605, and a proximal casing section 2611. Cannula 2600 isat least partially movably housed within a guiding tube 2602 and atleast partially houses a flexible wire 2614 configured to move therein,such as to protrude distally therefrom into the sinus cavity and togrind, chop and/or stir material present in the sinus cavity and/orinside cannula 2600. Flexible wire 2614 is shown herein as having a loopat a distal end thereof, which is an embodiment of a distal end of awire (which is also termed “flexible wire” or “grinding wire”) asdisclosed herein. Other distal shapes or forms, such as, a curve in thewire for example an L shaped curve are also covered under the scope ofthis disclosure.

Optionally, as shown in FIGS. 2A and 2B, cannula rotating mechanism 2635includes a dial 2640, and dial housing 2639. Optionally, dial 2640 isoperatively coupled to cannula 2600 and induces precession of cannula2600. Dial 2640 may be directly or indirectly coupled to cannula 2600.In a non-limiting example, precession of cannula 2600 may facilitatecannula insertion into patient sinus. Optionally, dial housing 2639 iscoupled to proximal casing section 2611. Optionally, dial housing 2639includes an opening in device casing 2611 that enable the user to rotatedial 2640 using his/her finger. According to some embodiments, device2000 is configured to enable the user to hold gripping handle 1609, suchthat two three or four fingers may conveniently interface with a distalsurface of distal gripper 1609 a and/or a thumb may convenientlyinterface with dial 2640, and/or index finger lay on cannula handle1608, and/or such that one, two or three fingers grasp syringe 1610.

According to some embodiments, dial 2640 comprises rotation marks, suchas 0-360 degrees marks. According to some embodiments, the rotationmarks provide the user an indication about the cannula's 2600 distal tip2629 bending orientation in space. According to some embodiments, theuser may use dial 2640, cannula handle 2607, cannula advancement marks2605 and the rotation marks to direct distal tip 2629 of cannula 2600and wire 2614 rotation to and from desired locations in the sinuscavity. According to some embodiments, the user may direct the rotationof wire 2614 towards the sinuses medial side. According to someembodiments, the user may direct the rotation of wire 2614 away frompotential nerves, blood vessels and/or other hazardous structures in thesinuses and/or ear cavity.

According to some embodiments, device 2000 may include a motor graspingmechanism such as a motor grasping handle 2670 or an o-ring 2672. Motorgrasping mechanism is configured to connect the motor 2613 to wirehandle 2612 or to device casing 2611. According to some embodiments,wire handle 2612 and casing 2611 comprises rails 2675 for orientationand smooth movement of handle 2612 within casing 2611. According to someother embodiments, motor 2613 may function as a handle as well as amotor. In such case motor 2613 and casing 2611 comprise rails 2675 fororientation and smooth movement of motor 2613 within casing 2611.

Reference is now made to FIGS. 3A, 3B, 3C which illustrate longitudinalcross sectional views of a device 3000 (which is substantially similarto device 2000 described in FIGS. 2A-B) that may be used for treating aparanasal sinus condition in a retracted, partially opened and openedconfigurations, respectively, and to FIGS. 3D, 3E, 3F and 3G which showenlargements of a distal section, a distal middle section, a proximalmiddle section and a proximal section of device 3000 in its openedconfiguration, respectively, according to some embodiments.

Device 3000 is substantially similar to device 2000 described in FIGS.2A-B with the notable difference that device 3000 further includes anaspiration channel 3660 operably coupled to a guiding tube 3602 ofdevice 3000 and facilitates aspiration of liquids from a sinus opening.As a non-limiting example, washing liquids applied into the sinus cavityby device 3000 via cannula 3600 may be aspirated via aspiration channel3660 of device 3000 as it flow out of the sinus opening around cannula3600 body. Cannula 1600 ends with a distal tip 3629, which may beatraumatic and/or may be closed. Optionally, wire 3614 protrudes out ofa side wall of cannula 3600.

Similarly to device 2000 of FIGS. 2A-B, device 3000 may include a distalcasing section 3605, and a proximal casing section 3611. A guiding tube3602 of device 3000 at least partially houses a flexible hollow cannula(“cannula”) 3600 movable therein, and a flexible wire 3614 which ismovable within cannula 3600.

Cannula 3600 is coupled, at a proximal section thereof, to a liquid tube3616, which is operably coupled to an irrigation/aspiration source forflowing liquids there through. Optionally, cannula 3600 and liquid tube3616 are interconnected by a cannula connector 3666 positioned within acentral lumen of guiding tube 3602 (as best shown in FIG. 3D) Accordingto some embodiments, liquid tube 3616 is stiffer than the cannula. Adiameter of a central lumen extending through liquid tube 3616 is largerthan a diameter of a central lumen extending through cannula 3600 tofacilitate a decrease of flow resistance for liquids therethrough. Adiameter of a central lumen extending through liquid tube 3616 is largerthan a diameter of a central lumen extending through cannula 3600 by atleast about 1mm, 2mm, 3mm,4mm, or 5mm Each possibility represents aseparate embodiment.

Wire 3614 extends within cannula 3600 and liquid tube 3616. Optionally,wire 3614 is coupled, at a proximal section thereof, to a wiretransmission shaft (“shaft”) 3615. Shaft 1615 extends from a connectingpoint with wire 3614, proximally to a wire handle 3612 and/or a motor3613. A distal part of shaft 3615 is located within the liquid tube3616. Optionally, operation of motor 3613 induces rotation of shaft 3615which transmits rotation movement to wire 3614. Shaft 3615 has a largerdiameter than wire 3614. According to some embodiments, shaft 3615 isstiffer and has higher torqueability and fatigue resistance than wire3614. Optionally, wire handle 3612 moves wire 3614 proximally anddistally within device 3000 by moving shaft 3615 which is coupledthereto. Wire handle 3612 may include a connector 3628, that connectsdistal rotating end of motor 3613 and shaft 1615 (as best shown in FIG.3G). According to some embodiments, a proximal end of connector 3628 anda distal end of motor 3613 have matching shapes such as in Allen key.According to some embodiments, the proximal end of connector 3628 andthe distal end of motor 3613 have magnetic connection or coupling.According to some embodiments, the proximal end of connector 3628 and/orthe distal end of motor 3613 include an alignment mechanism 3680, suchas a bearing. Optionally, wire handle 3612, and/or casing 3611 areshaped to grasp at least a portion of the motor body (e.g., thenon-rotating part of the motor).

Optionally, an element in the distal end of cannula connector 3666 or inthe shaft 3615 such as a socket, a bulb or a protrusion (not shown)prevents cannula 3600 occlusion by wire transmission shaft 3615 when itis advanced forward (distally) by a wire handle 3612.

In FIG. 3A, device 3000 is presented in a position similar to device1000 in FIG. 1A, where cannula 3600 and wire 3614 are both fullyproximally retracted, such that wire 3614 is positioned inside cannula3600 and does not protrude therefrom, and cannula 3600 is positionedinside guiding tube 3602 and does not protrude therefrom. Cannula handle3607 and wire handle 3612 are both fully proximally retracted.

In FIG. 3B, device 3000 is presented in a position where cannula 3600protrudes from distal end 3601 of guiding tube 3602 while wire 3614extends distally, pulling handle 3612 distally. It is still positionedinside cannula 3600 and does not protrude from a distal end of cannula3600. In order to reach such configuration, cannula handle 3607 wasmoved distally by a user (allowing cannula 3600 to protrude from distalend 3601 of guiding tube 3602) while wire handle 3612 was only partiallydistally pulled. Optionally, Liquid tube 3616 and shaft 3615 are linkedsuch that a proximal/distal movement of cannula handle 3607 istransmitted to a movement of wire 3614, shaft 3615 and wire handle 3612in the same direction as cannula 3600. The linkage enables to keep wire3614, in its relative position within cannula 3600 as the cannula ismoving forward. Such a movement may enable using a shorter cannula withless flow resistance and a shorter device. Full movement of wire handle3612 backward, will also mediate a proximal movement of cannula 3600 andcannula handle 3607. According to some embodiments, liquid tube 3616 andshaft 3615 linking mechanism may be a ring 3690 around shaft 3615 bodythat may be pulled by a narrowing structure 3695 in liquid tube 3616inner lumen or by its distal end.

In FIG. 3C, device 3000 is presented in a position similar to device1000 in FIG. 1B, where cannula 3600 fully protrudes from distal end 3601of guiding tube 3602 and wire 3614 extends distally and protruding froma distal end of cannula 3600. In order to reach such configuration, wirehandle 3612 was moved distally by a user (distally pushing wire 3614 viashaft 3615 to protrude from the distal end 3601 of cannula 3600). Inthis configuration both cannula 3600 and wire 3614 are fully distallyextending from device 3000. This configuration may also be referred toas an opened position of device 3000. Cannula 3600, liquid tube 3616,wire 3614 and the wire transmission shaft 3615 are advanced forward socannula 3600 is protruding out of guiding tube distal end 3601, the wire3614 is protruding out of the cannula 3600, and wire transmission shaft3615 is located within the liquid tube 3616 inside guiding tube 3602.

Reference is now made to FIG. 3E, which shows an enlargement of acannula handle portion of device 3000 of FIG. 3C (in an openedposition), according to some embodiments, to FIG. 3F, which shows anenlargement of a middle portion of device 3000 of FIG. 3C (in an openedposition), According to some embodiments, and to FIG. 3G, which shows anenlargement of a proximal portion of device 3000 of FIG. 3C (in anopened position), according to some embodiments.

In a middle section of device 3000, exists a T intersection 3620.According to some embodiments, the number of tubes in T intersection3620 is three or more. On its distal side T intersection 3620 isconnected to the liquid tube 3616. On its middle side T intersection3620 is connected to a syringe 3610, or to other type of irrigation/aspiration lines. Wire transmission shaft 3615 reaches T intersection3620 from a proximal side thereof and extends from its proximal side toits distal side (into the liquid tube 3616).

In order to enable simultaneously irrigation/aspiration and wire 3614rotation T intersection 3620 must be sealed to fluids and air from allits tubes. Therefore, according to some embodiments, T intersection 3620includes three seals around it: a cannula seal (may also be referred toas a liquid tube seal, or movable seal) 3618 (as best shown in FIG. 3F)is sealing T intersection 3620 from its distal side. A syringe seal (mayalso be referred to as an irrigation/aspiration seal) 3621, is sealingthe T intersection 3620 from its middle side. A wire transmission shaftseal (may also be referred to as a wire seal, or a wire/shaft seal or adynamic seal) 3622, is sealing the T intersection 3620 from its proximalside. A syringe seal 3621 is sealing the T intersection 3620 from itsmiddle side.

According to some embodiments, cannula seal 3618 is surrounding part ofthe liquid tube 3616. According to some embodiments, cannula seal 3618is positioned within defined lumen 3617. Optionally, lumen 3617 includesa distal and proximal ends and its shape is fitted to cannula seal 3618shape, such that no air or undesired liquids can penetrate to or escapeliquid tube 3616. Optionally, cannula seal 3618 is proximally anddistally movable within lumen 3617. According to some embodiments,cannula seal 3618 is attached to liquid tube 1616. Cannula seal 3618 maybe made of flexible material such as rubber of soft plastic as insyringe pistons. According to some embodiments, cannula seal 3618 ismade of syringe piston (or a structure similar thereto) and lumen 3617is made of syringe body (or a structure similar thereto). According tosome embodiments, cannula seal 3618 is made of one or more O-rings.According to some embodiments, cannula seal 3618 is surrounding ahousing 3619 that is attached to the liquid tube 3616. Housing 3619 isconfigured to prevent unintended migration of cannula seal 3618.According to some embodiments, the cannula seal 3618 seals the liquidtube 3616 both during movement forward and backward and during liquidtube 3616 and cannula 3600 rotation.

Acceding to some embodiments, syringe seal 3621 may be connected to oneor more syringes. According to other embodiments syringe seal 3621 maybe connected to irrigation/aspiration line or lines (not necessarilysyringe(s) as the name implies), such as motorized suction/irrigationmachine, sampling vials etc. Syringe seal 3621 is configured to seal theconnection between the irrigation/aspiration lines (such as, but notlimited to, a syringe) and T intersection 3620. Acceding to someembodiments, syringe seal 3621 may enable syringe/irrigation/aspirationlines replacement during the procedure. Acceding to some embodiments, auser may use one syringe for initial sinus irrigation (such as withsaline) and mucus sampling, and one or more additional syringes forirrigation with therapeutic substance. Acceding to some embodiments,syringe seal 3621 may be in a form of a locking luer. Acceding to someembodiments, syringe seal 3621 may be fitted only for certainsyringes/tubes/vials, depending on the need. This feature may preventmistakes such as using the wrong syringe for a certain procedure.Acceding to some embodiments, syringe seal 3621 and/or device grippinghandle distal end 3609 a and/or device gripping handle distal end 3609bmay prevent the user from using unintended syringe such as too bigsyringe by miss-fitting unintended syringe geometric properties.

Wire seal (which may also be referred to as a shaft seal, wiretransmission shaft seal or dynamic seal) 3622 is configured to seal theconnection between T intersection 3620 and motor 3613. Wire seal 3622also enable transmission of rotation movement from motor 3613 to wiretransmission shaft 3615 and or wire 3614. According to some embodiments,Wire seal 3622 enables transmission of rotation movement from motor 3613to wire transmission shaft 3615 and or wire 3614, and simultaneouslysealing connection between T intersection 3620 and motor 3613. Accordingto some embodiments, wire seal 3622 enables sealing under a rotationmovement in (RPM) equal or greater than about 100 rounds per minute(RPM), 500 RPM, 1000 RPM, 5,000 RPM, 10,000 RPM, 15,000 RPM, forexample, about 500-1500 RPM, 1000-5000 RPM, 4000-7000 RPM, 7500-12,000RPM. Each possibility represents a separate embodiment. According tosome embodiments, wire transmission shaft 3615 is movable back andforward (proximally and distally) trough wire seal 3622. Suitable sealtypes include, but are not limited to, dynamic seal, labyrinth seal andmagnetic seal.

According to some embodiments, wire seal 3622 includes one or moreO-rings that surrounds wire transmission shaft 3615. According to someembodiments, the O-ring(s) press on wire transmission shaft 3615.According to some embodiments, the O-ring(s) are being pressed on wiretransmission shaft 3615 by its environment. According to someembodiments, the O-ring(s) are lubricated or self-lubricated.

According to some embodiments, device 3000 further includes a mechanismthat connects cannula handle 3607 to liquid tube 3616 as it movetogether back and forth, but enable the liquid tube to rotate around itsaxis. According to some embodiments, pin 3626 connect cannula handle3607 to liquid tube 3616. According to some embodiments, connection ofpin 3626 to liquid tube 3616 is by liquid tube surrounding ring or widerpart in the liquid tube. According to some embodiments, the connectionbetween pin 3626 to liquid tube 3616 is linear, when one is beingadvanced or retrieved the other one is also being advanced or retrievedthe same distance. According to some embodiments, pin 3626 can also moveforward (distally) the wire transmission shaft 3615. Pin 3626 isprotruding via liquid tube 3616, and it is fitted to push a ring 3627located around liquid tube 3616.

A dial 3640 is shown in FIG. 3F, according to some embodiments, dial3640 is located within dial housing 3639. Optionally, dial 3640 isoperatively coupled to cannula 3600 and induces precession of cannula3600 at a distal end thereof. Dial 3640 may be operatively coupled tocannula 3600 via liquid tube 3616, and precession of liquid tube 3616transmits precession movement to cannula 3600. Optionally, rotation ofdial 3640 induces precession of liquid tube 3616 which transmitsprecession movement to cannula 3600. Alternatively, dial 3640 may bedirectly coupled to cannula 3600.

Dial housing 3639 includes an aperture for the user finger that allowsdial 3640 rotation. According to some embodiments, a dial interior part3641 connects dial 3640 to liquid tube 3616, which is connected tocannula 3600. According to some embodiments, a connection apparatus 3642between dial 3660 and liquid tube 3616 enables cannula 3600 rotationwith dial rotation and longitudinal movement of the liquid tube 3616without longitudinal movement of the dial. According to someembodiments, a connection apparatus 3642 between dial interior part 3641and liquid tube 3616 can be a protrusion and a socket. According to someembodiments, connection apparatus 3642 includes a long protrusion alongthe liquid tube 3616 and a fitted socket in round dial interior part3641, such that the socket may move along the long protrusion. Accordingto some embodiments, connection apparatus 3642 is located distally tothe movable cannula seal 3618. According to some embodiments, dialinterior part 3641 may stretch or extend its length within device casing3611 and over cannula seal 3618.

According to some embodiments, shaft 3615 may include several frictionand/or vibrating reduction mechanisms that reduce its friction and/orvibration against liquid tube 3616. According to some embodiments, themechanisms may be bearings, such as alignment mechanism 3680 or themotor bearing in the motor distal end. According to some embodiments,the mechanism, such as alignment mechanism 3680 may include a lowfriction surface such as Teflon washers. According to some embodiments,the mechanism may be a narrowing in liquid tube 3616 that centers shaft3615 with the center of liquid tube 3616 According to some embodiments,the narrowing, such as narrowing structure 3695 in liquid tube 3616 isconfigured to center the shaft and allow liquid flow in the liquid tube.According to some embodiments, wire transmission shaft seal 3622 alsomay serve as a friction and/or vibrating reduction mechanism. Accordingto some embodiments, device 3000 may include at least 2, 3, 4 frictionand/or vibrating reduction mechanisms, each represent a separateembodiment.

Reference is now made to FIG. 4A, which shows a distal portion of adevice 4000 that may be used for treating a paranasal sinus condition inan open configuration, according to some embodiments. Device 4000includes a stiff bent cannula 4600 and a wire 4614. Cannula 4600includes a curved distal section 4627 shaped to allow/facilitateinsertion into a sinus of a patient. Optionally, the insertion is into amaxillary sinus, a frontal sinus, a sphenoid sinus, or Eustachian tubes.Each possibility represents a separate embodiment, and may be combinedat will. According to some embodiments, cannula 4600 might be bent toangles of 110°-90° for the maxillary sinus, 0-30° for the sphenoidsinus, 60°-80° for the frontal sinus, 30°-70° for the Eustachian tubes.According to some embodiments, the cannula 4600 is bendable using a jigor via the user hands. According to some embodiments, the cannula 4600is made of a malleable material as steel.

According to some embodiments, cannula 4600 is operably coupled toaspiration machine or to a syringe, such as syringe 1610 of FIGS. 1A-B.According to some embodiments, such coupling is via a liquid tube suchas liquid tube 3616 of FIGS. 3A-G. According to some embodiments, wire4614 is connected to a motor such as motor 1613 of FIGS. 1A-B. Accordingto some embodiments, such connection is via a shaft, such as shaft 3615of FIGS. 3A-G. According to some embodiments, the movement of wire 4614and a shaft such as shaft 3615 forward and backward is controlled by awire handle, such as wire handle 3612 of FIGS. 3A-G. According to someembodiments, device 4000 may have a casing and a grip handle such as1605, 1611, 1609 a-b of FIGS. 1A-B. According to some embodiments,device 4000 may have sealing mechanisms such as seals 3620 and 3622 ofFIG. 3A-G. According to some embodiments, device 4000 may have bearingmechanisms similar to of device 3000 such as 3628 of FIGS. 3A-G.

Wire 4614 is configured is at least partially housed within cannula 4600and configured to distally protrude therefrom. Wire 4614 may beconfigured to rotate within curved distal section 4627 during sinusirrigation and/or sinus aspiration via curved distal section 4627. Wire4614 may be configured to protrude out of curved distal section 4627 androtate. According to some embodiments, rotating wire 4614 protrude outof atraumatic distal tip 4629. According to another embodiment, asdemonstrated in FIG. 4B a rotating wire 5614 protrusion out of a curveddistal section 5627 or atraumatic distal tip 5629 of cannula 5600 is aside fire protrusion.

Reference is now made to FIG. 4C, which shows a distal portion of adevice 6000 that may be used for treating a paranasal sinus condition inan opened configuration, according to some embodiments. Device 6000 issubstantially similar to device 4000, with the notable difference that acannula 6600 of device 6000 is at least partially housed by anaspiration tube 6630 configured for aspiration of fluids (e.g., liquidsspilled out of the sinus). Similarly to device 4000, device 6000includes cannula 6600 and a wire 6614. Wire 6614 may protrude laterallyout of a curved distal section 6627 of cannula 6602 or an atraumaticdistal tip 6629 thereof.

Optionally, aspiration tube 6630 such as guiding tube 6302 of FIG. 3A-Gis operably coupled to a second aspiration line such as aspirationmachine or to a syringe, such as aspiration channel 3660of FIGS. 3A-G.Optionally, a connector 6603 having a T or Y shape interconnectsaspiration tube 6630 and second aspiration tube 6632. Optionally, curveddistal section 6627 of cannula 6600 protrudes distally from aspirationtube 6630. In a non-liming example, curved distal section 6627 may be atleast partially inserted into a patient sinus or Eustachian tube, whileaspiration tube 6630 is not inserted into the sinus or Eustachian tube.Optionally, cannula 6600 may provide irrigation and or aspiration viadistal curved section 6627 while aspiration tube 6630 is operated toaspirate liquids spilled out of the sinus. In a non-limiting example,irrigation and/or aspiration is provided through distal curved section6627 and aspiration tube 6630 is operated to aspirate the liquidsspilled out of the sinus while rotating wire 6614 may be rotated withindistal curved section 6627 and/or within the sinus cavity.

According to some embodiments, aspiration tube 6630, connector 6603and/or second aspiration tube 6632 includes a syphon mechanism tocollect aspirated liquids or specimens from the sinus. Optionally, adistal end of aspiration tube 6630 is atraumatic. A distal portion ofaspiration tube 6630 may include an element 6631 made of soft materialand or collapsible construction such as foam. Optionally, element 6631circumferentially surrounds the distal end of tube 6630. Optionally,element 6631 is shaped as a ring and positioned proximally to the distalend of aspiration tube 6630. Optionally, element 6631 may be attached tothe sinus ostium during sinus irrigation and aspiration. According tosome embodiments, element 6631 may seal the sinus opening duringirrigation and may prevent irrigation liquid flow from the sinus to thenasal cavity.

Reference is now made to FIG. 5A which shows a distal portion of adevice 7000 a that may be used for treating a paranasal sinus conditionin an opened configuration, according to some embodiments. A needle 7632is positioned within an aspiration tube 7630. According to otherembodiments (not shown here) needle 7632 may be mounted on or positionedwithin a cannula such as cannula 6600 of FIG. 4C or a distal sectionthereof such as 6627 of FIG. 4C. Optionally, wire 7614 is aligned to fitwithin needle 7632 and assumes a predefined shape upon protrusiondistally therefrom. Optionally, device 7000 a further includes a spring7633 and spring stopping mechanism 7634 a and 7634 b configured to pressand advance needle 7632 into the sinus wall. Stopping mechanism 7634 aand 7634 b may limit needle 7632 advancement into the sinus to thedistance defined between 7634 a and 7634 b. Needle 7632 may be coupledto a liquid tube 7616, to allow a user to irrigate and aspirate thesinus via needle 7632, optionally, during wire 7614 rotation. In anon-limiting example, the user irrigates the sinus via needle 7632 andliquid tube 7616, during wire 7614 rotation and aspirate the spillingliquids via aspiration tube 7630.

According to some embodiments, device 7000 a has similar mechanisms todevice 6000 except of the needle 7632 is replacing cannula 6600.

According to some embodiments, device 7000 a has similar mechanisms todevice 3000, except from the needle 7632 is that replacing cannula 3600,the lack of cannula actuation and sealing mechanisms, and the aspirationtube 7630 that replace guiding tube 3602. According to some embodiments,needle 7632 is operably coupled to aspiration machine or to a syringe,such as syringe 1610 of FIGS. 1A-B. According to some embodiments, suchcoupling is via a liquid tube such as liquid tube 3616 of FIGS. 3A-G.According to some embodiments, wire 7614 is connected to a motor such asmotor 1613 of FIGS. 1A-B. According to some embodiments, such connectionis via a shaft, such as shaft 3615 of FIGS. 3A-G. According to someembodiments, wire 7614 and shaft (such as shaft 3615 3615 of FIGS. 3A-Gmovement forward and backward is controlled by a wire handle, such aswire handle 3612 of FIGS. 3A-G. According to some embodiments, device7000 a may have a casing and a grip handle such as 1605, 1611, 1609 a-bof FIGS. 1A-B. According to some embodiments, device 7000 a may havesealing mechanisms such as seals 3620 and 3622 of FIGS. 3A-G. Accordingto some embodiments, device 7000 a may have bearing mechanisms similarto connector 3628 of device 3000 of FIGS. 3A-G.

Reference is now made to FIG. 5B, which shows a distal portion of adevice 7000 b that may be used for treating a paranasal sinus conditionin an opened configuration, according to some embodiments. According tosome embodiments, a cannula 7600 is protruding out of a distal tip ofneedle 7632. According to some embodiments, device 7000 b has similarmechanisms to device 3000, except for needle 7632 instead of distal end3601 of guiding tube 3602. According to some embodiments, cannula 7600is operably coupled to aspiration machine or to a syringe, such assyringe 1610 of FIGS. 1A-B. According to some embodiments, such couplingis formed via a liquid tube such as liquid tube 3616 of FIGS. 3A-G.According to some embodiments, wire 7614 is connected to a motor such asmotor 1613 of FIGS. 1A-B. According to some embodiments, such connectionis formed via a shaft, such as shaft 3615 of FIGS. 3A-G. According tosome embodiments, wire 7614 and shaft 3615 movement forward and backwardis controlled by a wire handle, such as wire handle 3612 of FIGS. 3A-G.According to some embodiments, device 7000 b may have a casing and agrip handle such as 1605, 1611, 1609 a-b of FIGS. 1A-B. According tosome embodiments, device 7000 b may have sealing mechanisms such asseals 3620 and 3622 of FIGS. 3A-G. According to some embodiments, device7000 b may have similar bearing mechanisms to device 3000 such as 3628of FIGS. 3A-G.

Reference is now made to FIGS. 8A, 8B, 8C, and 8D which show a distalportion of a cannula 8600 of a device 8000 that may be used for treatinga paranasal sinus condition, each according to a different embodiment.

Referring to FIGS. 8A and 8C, a nitinol loop 8636 protrudes from adistal end of cannula 8600. Nitinol loop 8636 may include curves, bulbsor protrusions such as protrusions 8637 a and 8637 b that prevents itfrom retrieving into cannula 8600. Optionally, a metal crimp 8638interconnects nitinol loop 8636 and a wire 8614.

Referring to FIG. 8B, a nitinol loop 8636 b which protrudes from adistal end of cannula 8600 may include an offsite angle portion and maybe rotated to facilitate its insertion into the sinus opening, such asby a motor (e.g., motor 1613 of FIGS. 1A and 1B).

Referring to FIG. 8D, a nitinol loop 8636 a partially protrudes from adistal end of cannula 8600 and may be utilized as an atraumatic tip forcannula 8600.

Certain embodiments of the present disclosure may include some, all, ornone of the above advantages. One or more technical advantages may bereadily apparent to those skilled in the art from the figures,descriptions and claims included herein. Moreover, while specificadvantages have been enumerated above, various embodiments may includeall, some or none of the enumerated advantages.

In addition to the exemplary aspects and embodiments described above,further aspects and embodiments will become apparent by reference to thefigures and by study of the following detailed descriptions. It isunderstood that certain elements or configurations illustrated in aspecific figure/embodiment may be included in other figures/embodimentand that various combination of elements and/or configurations arepossible.

What we claim is:
 1. A medical device for treating and/or diagnosing asinus and/or ear condition, said medical device comprising: a housingcomprising or functionally connected to: a hollow cannula defining alumen extending at least partially along the length thereof, the cannulais configured to be at least partially inserted through an ostium into asinus cavity/ear of a subject; a flexible grinding wire, positionedwithin the cannula's lumen, or alongside it, and configured to be atleast partially inserted through an ostium into a sinus cavity/ear of asubject, and to rotate along a longitudinal axis thereof and therebygrind, chop and/or stir material present in said sinus cavity and/orinside said hollow cannula; a liquid tube defining a lumen extending atleast partially along the length thereof, wherein the liquid tubeconnecting the cannula with an irrigation/ aspiration source; and ashaft functionally connecting the grinding wire with a motor, to therebyallow rotating the grinding wire within the cannula lumen and/or thesinus cavity.
 2. The device of claim 1, further comprising a mechanismfor sealing the connection between the shaft and the cannula/liquid tubeduring rotational and/or forwarded and backward movement of the shaftrelative to the cannula/liquid tube, wherein said mechanism isconfigured to allow irrigation or aspiration via the cannula/liquid tubewhile the shaft/wire are at least partially positioned within the liquidtube/ cannula's lumen without backflow or spillage of gas or liquids. 3.The device of claim 1, further comprising a wire handle functionallyconnected to the wire, allowing a user to advance and retrieve the wirewithin the cannula or alongside the cannula, and into and out of thesinus/ear lumen, wherein the device is handheld by a gripping handle. 4.The device of claim 3, wherein the motor serves as the wire handle. 5.The device of claim 2, wherein the sealing mechanism comprises acannula/liquid tube seal located within a defined lumen within thehousing and surrounding at least portion of the cannula/liquid tube,such that the cannula/liquid tube is distally/proximally movable withinthe lumen and relative to the handle grip while remaining thecannula/liquid tube cavity sealed from air inlet and liquid outletduring irrigation and aspiration, wherein the cannula/liquid tube sealis further configured to facilitate rotation of the cannula/liquid tubewhile the cannula/liquid tube remains sealed.
 6. The device of claim 2,wherein the sealing mechanism comprises a wire/shaft seal surrounding atleast portion of the wire/shaft and facilitating distal/proximalmovement of the wire/shaft within and relative to the cannula/liquidtube, while maintaining the cannula/liquid tube sealed from air inletand liquids outlet during irrigation and aspiration, wherein thewire/shaft seal is further configured to facilitate high RPM rotation ofthe wire/shaft within and relative to the cannula/liquid tube, while thecannula/liquid tube remains sealed.
 7. The device of claim 2, whereinthe sealing mechanism comprises an irrigation/ aspiration sealconfigured for connection and/or detachment of irrigation/ aspirationsource to the liquid tube/cannula in a sealed manner.
 8. The device ofclaim 1, further comprising a cannula handle functionally connected tothe cannula, allowing a user to advance and retrieve the cannula into asinus cavity or an ear.
 9. The device of claim 1, further comprisingstraight or banded guiding tube configured to house the cannula thereinand bend the cannula as it is being advanced forward, and direct adistal end of the cannula towards a sinus opening.
 10. The device ofclaim 1, further comprising a curve in said cannula distal tip and acannula rotating mechanism, configured to allow the user to rotate adistal tip of the cannula around a longitudinal axis of the cannula,thus facilitate insertion of the cannula into the sinus cavity.
 11. Thedevice of claim 9, further comprising a connector configured forreplacing of guiding tubes.
 12. The device of claim 9, furthercomprising a mechanism for changing an angle of a distal section of theguiding tube, to facilitate introduction of the cannula to various sinusregions.
 13. The device of claim 1, wherein the irrigation/aspirationsource comprises a replaceable syringe, a syphon, and/or a liquidcontainer.
 14. The device of claim 1, further comprising a connectorconnecting between the liquid tube/cannula and the shaft/wire such thatwhen the liquid tube/cannula is moved distally or proximally, theshaft/wire will also be respectively moved distally or proximally, forat least part of the liquid tube/cannula advancement.
 15. The device ofclaim 1, further comprising one or more side ports in the guiding tubeor on the housing, wherein the side port are configured forinstrumentation insertion through a distal end of the guiding tube. 16.The device of claim 15, wherein the side port is configured to serve asan aspiration port being in fluid flow connection with a distal end ofthe guiding tube, wherein the aspiration port is configured for suctionof aspiration/irrigation fluid from the guiding tube.
 17. The device ofclaim 1, further comprising a hollow trocar configured to house saidcannula therein, puncture a sinus wall, sinus floor or ear wall andfacilitate insertion of said cannula into the sinus/ear cavity, orwherein the cannula is configured to puncture via an ear or a sinus wallor sinus floor as a trocar.
 18. The device of claim 9, furthercomprising visualization equipment located within or mounted on a distaltip of the guiding tube.
 19. The device according to claim 1, furthercomprising one or more additional diagnostic and/or therapeuticinstrument, selected from: guidewire, light-wire for trans-illumination,optic fiber for visualization or recording, optic fiber for pathogeneradication, swab, cutting device, balloon, dilatation device, vibratingpiezoelectric crystal, laser or heat source, absorbable material soakedwith drug, or any combination thereof.
 20. The device of claim 1,further comprising a cannula position marking configured to provideindication regarding the cannula's distal end location and/ororientation in relation to a sinus opening,
 21. The device of claim 8,further comprising a locking mechanism for locking the cannula/ liquidtube at a desired position, wherein the locking mechanism is configuredto be manually or automatically operable and is located in or connectedto the cannula handle/device housing.